sodium bicarbonate
Approved
Dec 7, 1953
Diammonium carbonate is a salt with the chemical formula (NH4)2CO3. Since it readily degrades to gaseous ammonia and carbon dioxide upon heating, it is used as a leavening agent and also as smelling salt. Ammonium carbonate may be used as a leavening agent in traditional recipes, particularly those from northern Europe and Scandinavia (e.g. Speculoos, Tunnbröd or Lebkuchen). It also serves as an acidity regulator and has the E number E503. Ammonium carbonate is the main component of smelling salts, although the commercial scale of their production is small. Buckley's cough syrup from Canada today uses ammonium carbonate as an active ingredient intended to help relieve symptoms of bronchitis. Ammonium carbonate is also used as an emetic. — NCATS
Clinical trial activity
271 trials · 277 clinical orgs · 66 marketing orgs
Earliest trial started Jun 24, 1996 (NCT06046924)
Timeline
1950s
- Dec 7, 1953
Evidence of US Marketing
- Dec 7, 1953
Earliest FDA Approval
- Dec 7, 1953
DAVA Pharmaceuticals — Marketing Organization
1970s
- Sep 5, 1979
Bristol-Myers — Marketing Organization
1980s
- Oct 28, 1981
Nestle — First NDA Organization
- Oct 28, 1981
Alcon — Marketing Organization
- Oct 28, 1981
Nestle — NDA Secondary Org
- Oct 28, 1981
Nestle — NDA Organization
- Jul 13, 1984
Braintree Laboratories — Marketing Organization
- Jul 13, 1984
Braintree Laboratories — NDA Secondary Org
- Oct 26, 1984
Mylan — NDA Secondary Org
- Feb 14, 1985
Bristol-Myers Squibb — Marketing Organization
- Aug 7, 1985
Mallinckrodt — Marketing Organization
- Aug 7, 1985
Avon Products — NDA Secondary Org
- Apr 30, 1986
Hospira — NDA Secondary Org
- May 9, 1986
Norbrook — Marketing Organization
- Jun 3, 1986
Abbott — NDA Secondary Org
- Jun 13, 1986
Abraxis — Marketing Organization
- Sep 16, 1986
West-Ward Pharmaceutical — Marketing Organization
- Apr 20, 1988
Dynapharm — Marketing Organization
- Dec 23, 1988
Goldline — Marketing Organization
1990s
- Oct 15, 1990
Barr Laboratories — Marketing Organization
- Aug 23, 1991
Pharmacia & Upjohn — Marketing Organization
- Nov 27, 1991
Akorn, Inc. — Marketing Organization
- Nov 27, 1991
Akorn, Inc. — NDA Secondary Org
- Nov 27, 1991
Epic Pharma Llc — NDA Secondary Org
- Jan 28, 1992
Vintage — Marketing Organization
- Aug 1, 1994
Hikma — Marketing Organization
- Sep 27, 1996
Lukare Medical — Marketing Organization
- Sep 27, 1996
Lukare Medical — NDA Secondary Org
- Feb 26, 1999
Fresenius — Marketing Organization
- Jun 17, 1999
Duramed Research — Marketing Organization
2000s
- Jan 1, 2004
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2004
Earliest Phase 3 Sponsor(trial)
- Jun 15, 2004
Salix — NDA Secondary Org
- Dec 21, 2004
Santarus — Marketing Organization
- Dec 21, 2004
Santarus — NDA Secondary Org
- Nov 9, 2005
Hospira — Marketing Organization
- Jan 1, 2006
Earliest Phase 2 Sponsor(trial)
- Jul 26, 2006
Henry Schein, Inc — NDA Secondary Org
- Jul 26, 2006
Watson Pharmaceuticals — NDA Secondary Org
- Oct 25, 2006
Baxalta — Marketing Organization
- Oct 25, 2006
Baxalta — NDA Secondary Org
- Apr 30, 2007
Accord Research — Marketing Organization
- Mar 31, 2009
Sandoz — Marketing Organization
- May 27, 2009
Novel Anti-Infective Technologies, LLC — Marketing Organization
- Dec 1, 2009
Bayer — Marketing Organization
- Dec 1, 2009
RILEY CONSUMER — NDA Secondary Org
2010s
- Jan 8, 2010
Pharmachemie Bv — Marketing Organization
- Jan 28, 2010
Mylan — Marketing Organization
- Feb 25, 2010
Paddock Laboratories — Marketing Organization
- May 25, 2010
Par Pharmaceuticals — Marketing Organization
- Apr 13, 2015
Strides Pharma Science — Marketing Organization
- May 21, 2015
Sun Pharmaceuticals — Marketing Organization
- Mar 4, 2016
Pfizer — Marketing Organization
- Jul 15, 2016
Unicorn Pacific Corporation — Marketing Organization
- Jul 15, 2016
Actavis — Marketing Organization
- Jul 15, 2016
Ajanta Pharma Ltd — Marketing Organization
- Jul 15, 2016
Dr. Reddy's Laboratories — Marketing Organization
- Jul 15, 2016
Perrigo — Marketing Organization
- Jul 15, 2016
Chartwell Pharmaceuticals — Marketing Organization
- Aug 19, 2016
Aurobindo Pharma — Marketing Organization
- Dec 6, 2016
Sciegen Pharmaceticals — Marketing Organization
- Mar 8, 2017
Esteve Labs — Marketing Organization
- Mar 8, 2017
Nostrum Laboratories — Marketing Organization
- Apr 25, 2017
Silvergate Pharmaceuticals — Marketing Organization
- Apr 25, 2017
Azurity — Marketing Organization
- Sep 19, 2017
International Medication — Marketing Organization
- Dec 22, 2017
Amneal Pharmaceuticals — Marketing Organization
- Mar 16, 2018
Zydus Discovery DMCC — Marketing Organization
- Aug 9, 2018
Sagent Pharmaceuticals, Inc. — Marketing Organization
- Jun 20, 2019
Exela Pharma Sciences, LLC. — Marketing Organization
2020s
- Jan 30, 2020
Eugia Pharma — Marketing Organization
- Apr 30, 2020
Guardian Drug — Marketing Organization
- Apr 30, 2020
ANDA Repository — Marketing Organization
- Apr 23, 2021
Lotus Pharmaceutical — Marketing Organization
- Aug 30, 2022
Azurity — NDA Secondary Org
- Jun 15, 2023
OMNIVIUM PHARMS — Marketing Organization
- Jun 28, 2023
STERISCIENCE — Marketing Organization
- Aug 7, 2023
Daito Pharmaceuticals — Marketing Organization
Indications
Approved for
Studied for
- Accidental Falls · Phase 2
- Acidosis · Phase 4
- Acute Kidney Injury · Phase 4
- Anemia, Sickle Cell · Phase 1
- Anesthesia · Phase 4
- Anesthesia, General · Phase 1
- Anesthesia, Local · Phase 4
- Aortic Valve Disease · Phase 4
- Behavior · Phase 4
- Blood Pressure · Phase 4
- Body Weight · Phase 4
- Brain Edema · Early Phase 1
- Cardiopulmonary Bypass · Phase 2/Phase 3
- Cathartics · Phase 4
- Catheterization, Central Venous · Phase 2
- Catheter-Related Infections · Phase 4
- Catheters · Phase 4
- Cells · Phase 4
- Cesarean Section · Phase 3
- Cholecystectomy, Laparoscopic · Phase 4
- Colonoscopy · Phase 4
- Colorectal Neoplasms · Phase 2
- Contrast Media · Phase 4
- Coronary Artery Disease · Phase 4
- Coronary Disease · Phase 4
- Coronavirus · Phase 4
- Coronavirus Infections · Phase 4
- COVID-19 · Phase 4
- Critical Care · Phase 4
- Cystic Fibrosis · Phase 1
- Cystitis, Interstitial · Phase 2
- Death, Sudden, Cardiac · Phase 4
- Diabetes Mellitus · Phase 2
- Diabetes Mellitus, Type 1 · Phase 4
- Diabetic Nephropathies · Phase 4
- Dialysis · Phase 4
- Diarrhea · Phase 1/Phase 2
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Drugs, Investigational · Phase 4
- Electrolytes · Phase 4
- Esophagitis · Phase 4
- Extravasation of Diagnostic and Therapeutic Materials · Phase 2/Phase 3
- Fatigue · Phase 2
- Filtration · Phase 2/Phase 3
- Fractures, Bone · Phase 2
- Gastric Acid · Phase 3
- General Surgery · Phase 4
- Gout · Phase 4
- Hamartoma · Phase 4
- Headache · Phase 2/Phase 3
- Head and Neck Neoplasms · Phase 2
- Healthy Volunteers · Phase 4
- Heart Arrest · Phase 4
- Heartburn · Phase 4
- Heart Defects, Congenital · Phase 2
- Heart Diseases · Phase 2
- Heart Function Tests · Phase 4
- Helicobacter Infections · Phase 3
- Helicobacter pylori · Phase 2/Phase 3
- Hematologic Diseases · Phase 2
- Hematologic Neoplasms · Phase 1
- Hemodialysis, Home · Phase 4
- HIV · Phase 1
- Human Experimentation · Phase 3
- Hydrogen-Ion Concentration · Phase 4
- Hypertension · Phase 1
- Hypokalemia · Phase 4
- Hypotension · Phase 4
- Insulin Resistance · Phase 2
- Intestinal Failure · Phase 2
- Intestine, Large · Phase 3
- Kidney Calculi · Phase 4
- Kidney Diseases · Phase 4
- Kidney Failure, Chronic · Phase 4
- Kidney Transplantation · Phase 4
- Labor, Obstetric · Phase 3
- Leukemia, Myeloid, Acute · Early Phase 1
- Live Birth · Phase 3
- Lung Neoplasms · Phase 4
- Lymphoma · Phase 1
- Membranes · Phase 4
- Mitochondrial Diseases · Phase 2
- Mucositis · Phase 4
- Multiple Myeloma · Phase 1
- Muscle Hypotonia · Phase 2
- Neoplasm Metastasis · Phase 2
- Neoplasms · Phase 3
- Nephrolithiasis · Phase 4
- Obesity · Phase 1
- Obstetric Labor Complications · Phase 3
- Oliguria · Phase 2
- Ondansetron · Phase 4
- Oral Hygiene · Phase 4
- Oropharyngeal Neoplasms · Phase 3
- Osteoarthritis · Phase 2/Phase 3
- Osteoporosis · Phase 2
- Overweight · Phase 1
- Pancreatic Neoplasms · Phase 1
- Pelvic Pain · Phase 3
- Performance-Enhancing Substances · Early Phase 1
- Pharmacokinetics · Phase 1
- Physical Endurance · Phase 2
- Pneumonia · Early Phase 1
- Poisoning · Phase 4
- Polycystic Kidney, Autosomal Dominant · Phase 2
- Postoperative Nausea and Vomiting · Phase 4
- Pregnancy Complications · Phase 3
- Prostatic Neoplasms · Phase 1/Phase 2
- Pulmonary Embolism · Phase 4
- Pulmonary Ventilation · Early Phase 1
- Pulpitis · Phase 4
- Renal Artery Obstruction · Phase 4
- Renal Dialysis · Phase 1
- Renal Insufficiency · Phase 4
- Renal Insufficiency, Chronic · Phase 4
- Renal Replacement Therapy · Phase 2
- Rhytidoplasty · Phase 3
- Safety · Phase 4
- Saline Solution, Hypertonic · Early Phase 1
- Sarcoma · Phase 2
- Shock · Phase 3
- Shock, Septic · Phase 4
- Sports · Phase 3
- Stomach Diseases · Phase 3
- Stomach Neoplasms · Early Phase 1
- Stomach Ulcer · Phase 1
- Stomatitis · Phase 4
- Surgical Wound Infection · Phase 2/Phase 3
- Systemic Inflammatory Response Syndrome · Phase 2
- Thoracic Surgery · Phase 2/Phase 3
- Urinary Bladder Diseases · Phase 2
- Urinary Bladder, Overactive · Phase 4
- Urinary Incontinence, Stress · Phase 2
- Urinary Incontinence, Urge · Phase 4
- Varicose Veins · Phase 4
- Vascular Access Devices · Phase 4
- Vascular Diseases · Phase 4
- Venous Cutdown · Phase 2/Phase 3
- Venous Thromboembolism · Phase 2/Phase 3
Mechanism of action
- Unspecified targetBuffer
buffer
Combination products
baros
with tartaric acid
bss plus
with potassium chloride, sodium phosphate, sodium chloride, calcium chloride, glucose monohydrate, glutathione, magnesium
Also known as methotrexate sodium
elliotts b solution
with potassium chloride, magnesium sulfate, sodium phosphate, sodium chloride, calcium chloride, glucose monohydrate
golytely
with potassium chloride, sodium sulfate, sodium chloride, polyethylene glycol
Also known as clenz-lyte, co-lav, colovage, colyte, colyte-flavore, colyte with flavor packs, glycoprep, go-evac, ocl, peg 3350 and electrolytes, polyethylene glycol 3350 and electrolytes
halflytely
with bisacodyl, potassium chloride, sodium chloride, polyethylene glycol
Also known as peg-3350, sodium chloride, sodium bicarbonate, potassium chloride and bisacodyl
navstel
with potassium chloride, sodium phosphate, sodium chloride, oxiglutatione, calcium chloride, glucose monohydrate, magnesium
normocarb hf
with sodium chloride, magnesium
nulytely-flavore
with potassium chloride, sodium chloride, polyethylene glycol
Also known as lax-lyte with flavor packs, nulytely, peg-3350, potassium chloride, sodium bicarbonate, sodium chloride, trilyte
phoxillum bk
with potassium chloride, sodium phosphate, sodium chloride, calcium chloride, magnesium
Also known as phoxillum b22k
prismasol bk
with potassium chloride, lactic acid, sodium chloride, calcium chloride, glucose monohydrate, magnesium
Also known as prismasol b22gk, prismasol bgk
suclear
with potassium chloride, magnesium sulfate, potassium sulfate, sodium sulfate, sodium chloride, polyethylene glycol
zegeri
with omeprazole
Also known as zegerid otc
Approval history
- approvedPriority reviewDec 7, 1953
- approvedPriority reviewDec 7, 1953
Chemistry & pharmacology
SMILES
OC([O-])=O- Mol. weight
- 61.0168 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- Yes
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Availability
- Over the Counter
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaBicarbonate ↗
- NCATSHN1ZRA3Q20 ↗
- ChEMBLCHEMBL1353 ↗
- ChEMBLCHEMBL1161632 ↗
- ChEMBLCHEMBL2106975 ↗
- WikipediaDialysis (chemistry) ↗
- WikipediaDialysis ↗
- WikipediaSodium bicarbonate ↗
- ChEMBLCHEMBL186314 ↗
Also known as
- alka seltzer
- alka seltzer
- anhydrous sodium carbonate
- anhydrous sodium carbonate
- ash
- ash
- baking soda
- baking soda
- baking soda
- bicarbinate
- bicarbonate
- bicarbonate
- bicarbonate of soda
- bicarbonate of soda
- carbonic acid, disodium salt
- carbonic acid, disodium salt
- carbonic acid monopotassium salt
- carbonic acid, monopotassium salt
- carbonic acid, monopotassium salt
- carbonic acid monosodium salt
- carbonic acid monosodium salt
- carbonic acid sodium salt
- carbonic acid sodium salt (1:2)
- carbonic acid sodium salt (1:2)
- dialysate
- dialysate sodium
- disodium carbonate
- disodium carbonate
- disodium carbonate
- disodium carbonate, 14c-labeled cpd
- disodium carbonate, heptahydrate
- disodium carbonate, monohydrate
- e500
- e500
- e500
- e 500
- e 500
- e-500
- e-500
- fraxinus
- k2co3
- khco3
- kondrium
- monopotassium carbonate
- monosodium carbonate
- monosodium carbonate
- monosodium carbonate, 14c-labeled cpd
- monosodium carbonate, monohydrate
- nahco3
- nahco3
- natriumhydrogenkarbonat
- natriumhydrogenkarbonat
- natriumkarbonat
- natriumkarbonat
- natrum carbonicum
- natrum carbonicum
- neut
- neut
- nurse harveys
- peritoneal dialysis fluid
- potassium bicarbonate
- potassium bicarbonate
- potassium bicarbonate
- potassium bicarbonate
- potassium bicarbonate
- potassium bicarbonate
- potassium bicarbonate
- potassium carbonate
- potassium carbonate
- potassium carbonate
- potassium carbonate sesquihydrate
- potassium hydrocarbonate
- potassium hydrogencarbonate
- potassium hydrogencarbonate
- potassium hydrogencarbonate
- potassium hydrogen carbonate
- potassium hydrogen carbonate
- potassium hydrogen carbonate
- pot eff
- s-bicarb
- s-bicarb sf
- soda ash
- soda ash
- soda-ash
- soda-ash
- soda mint
- soda mint
- sodibic
- sodium acid carbonate
- sodium acid carbonate
- sodium bicarbonate
- sodium bicarbonate
- sodium bicarbonate
- sodium bicarbonate
- sodium bicarbonate
- sodium bicarbonate
- sodium bicarbonate
- sodium bicarbonate
- sodium bicarbonate
- sodium carbonate
- sodium carbonate
- sodium carbonate
- sodium carbonate
- sodium carbonate
- sodium carbonate
- sodium carbonate
- sodium carbonate (2:3), dihydrate
- sodium carbonate (4:5)
- sodium carbonate anhydrous
- sodium carbonate anhydrous
- sodium carbonate anhydrous
- sodium carbonate (anhydrous)
- sodium carbonate (anhydrous)
- sodium carbonate, anhydrous
- sodium carbonate, anhydrous
- sodium carbonate decahydrate
- sodium carbonate, hydrate
- sodium hydrogencarbonate
- sodium hydrogencarbonate
- sodium hydrogen carbonate
- sodium hydrogen carbonate
- sodium hydrogen carbonate
- sodium hydrogen carbonate
- sodium salt of carbonic acid
- sodium salt of carbonic acid
- thamicarb
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07273539 | N/A | Oct 27, 2025 | Healeon Medical Inc, University of Birmingham |
| NCT07010744 | N/A | Jun 30, 2025 | Dhaka Medical College |
| NCT07008222 | N/A | Jun 30, 2025 | University of California, San Diego |
| NCT06999993 | Phase 2/Phase 3 (Phase 3) | Jun 20, 2025 | Misr University for Science and Technology |
| NCT06955871 | N/A | Apr 29, 2025 | Colgate Palmolive |
| NCT06661902 | Phase 1/Phase 2 (Phase 2) | Feb 28, 2025 | University of Washington |
| NCT06270134 | N/A | Jan 31, 2025 | Canadian Institutes of Health Research (CIHR), McMaster University, University of Western Ontario |
| NCT06632184 | Phase 4 | Dec 6, 2024 | Instituto Mexicano del Seguro Social |
| NCT06335537 | Phase 1 | Oct 31, 2024 | University of California, Irvine |
| NCT06591494 | Phase 2/Phase 3 (Phase 3) | Sep 15, 2024 | Zhejiang University |
| NCT06579690 | Phase 3 | Sep 1, 2024 | Busitema University, Cures Within Reach, Open Philanthropy Project, University of Liverpool, University of Oslo |
| NCT06249061 | N/A | Jun 30, 2024 | McMaster University, Trillium Health Partners, University of Western Ontario |
| NCT06622525 | N/A | May 1, 2024 | Hospital General de Mexicali, Universidad Autonoma de Baja California |
| NCT06966635 | Phase 4 | Apr 10, 2024 | Fudan University |
| NCT06734481 | N/A | Apr 1, 2024 | Ningbo University |
| NCT06292091 | Phase 1 | Feb 28, 2024 | Seoul National University |
| NCT07312721 | Phase 4 | Jan 5, 2024 | Shahida Islam Medical Complex |
| NCT06186622 | Phase 1 | Jan 2, 2024 | Eli Lilly |
| NCT06047366 | Phase 4 | Dec 5, 2023 | Indiana University, United States Army |
| NCT05814146 | Phase 4 | Aug 31, 2023 | Harvard University |
Organizations
Research & Development (277)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Bayer | For profit | 7 | 7 | 3 | 2008 |
| University of Colorado, Denver | Academic/Hospital | 6 | 6 | 2 | 2014 |
| Department of Veteran Affairs | Government | 5 | 3 | 4 | 2008 |
| GlaxoSmithKline | For profit | 5 | 5 | 3 | 2012 |
| Mansoura University | Academic/Hospital | 5 | 4 | 3 | 2018 |
| Austin Health | Academic/Hospital | 4 | 4 | 2 | 2006 |
| Isfahan University | Academic/Hospital | 4 | 2 | 2 | 2007 |
| University of Zurich | Academic/Hospital | 4 | 4 | 3 | 2011 |
| Aarhus University | Academic/Hospital | 3 | 2 | 2 | 2010 |
| Ain Shams University | Academic/Hospital | 3 | 2 | 2 | 2020 |
| Alexandria University | Academic/Hospital | 3 | 3 | 2 | 2018 |
| Bausch Health Companies | For profit | 3 | 1 | 2 | 2008 |
| Cairo University | Academic/Hospital | 3 | 2 | 2 | 2018 |
| DLR German Aerospace Center | Academic/Hospital | 3 | 3 | 1 | 2007 |
| Indiana University | Academic/Hospital | 3 | 2 | 2 | 1999 |
| Mayo Clinic | Academic/Hospital | 3 | 2 | 2 | 2008 |
| McMaster University | Academic/Hospital | 3 | 3 | 1 | 2018 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Government | 3 | 0 | 3 | 2011 |
| Ospedale Misericordia e Dolce, Prato | Academic/Hospital | 3 | 3 | 1 | 2004 |
| Poznan University | Academic/Hospital | 3 | 3 | 1 | 2014 |
Marketing (95)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ANDA Repository | For profit | MKTG | Apr 30, 2020 |
| Abbott | For profit | NDA2 | Jun 3, 1986 |
| Abraxis | For profit | MKTG | Jun 13, 1986 |
| Accord Research | For profit | MKTG | Apr 30, 2007 |
| Actavis | For profit | MKTG | Jul 15, 2016 |
| Ajanta Pharma Ltd | For profit | MKTG | Jul 15, 2016 |
| Akorn, Inc. | For profit | MKTG | Nov 27, 1991 |
| Akorn, Inc. | For profit | NDA2 | Nov 27, 1991 |
| Alcon | For profit | MKTG | Oct 28, 1981 |
| Alcon | For profit | SYN | Jul 24, 2008 |
| Amneal Pharmaceuticals | For profit | MKTG | Dec 22, 2017 |
| Aurobindo Pharma | For profit | MKTG | Aug 19, 2016 |
| Aurobindo Pharma | For profit | SYN | Nov 7, 2016 |
| Aurobindo Pharma | For profit | SYN | Feb 5, 2004 |
| Avon Products | For profit | NDA2 | Aug 7, 1985 |
| Azurity | For profit | MKTG | Apr 25, 2017 |
| Azurity | For profit | NDA2 | Aug 30, 2022 |
| Barr Laboratories | For profit | MKTG | Oct 15, 1990 |
| Baxalta | For profit | MKTG | Oct 25, 2006 |
| Baxalta | For profit | NDA2 | Oct 25, 2006 |
| Bayer | For profit | MKTG | Dec 1, 2009 |
| Braintree Laboratories | For profit | MKTG | Jul 13, 1984 |
| Braintree Laboratories | For profit | SYN | Jan 18, 2013 |
| Braintree Laboratories | For profit | NDA2 | Jul 13, 1984 |
| Bristol-Myers | For profit | MKTG | Sep 5, 1979 |
| Bristol-Myers Squibb | For profit | MKTG | Feb 14, 1985 |
| Bristol-Myers Squibb | For profit | SYN | Apr 14, 1989 |
| Chartwell Pharmaceuticals | For profit | MKTG | Jul 15, 2016 |
| DAVA Pharmaceuticals | For profit | MKTG | Dec 7, 1953 |
| Daito Pharmaceuticals | For profit | MKTG | Aug 7, 2023 |
| Dr. Reddy's Laboratories | For profit | MKTG | Jul 15, 2016 |
| Dr. Reddy's Laboratories | For profit | SYN | Jul 15, 2016 |
| Duramed Research | For profit | MKTG | Jun 17, 1999 |
| Dynapharm | For profit | MKTG | Apr 20, 1988 |
| E Z EM | For profit | MKTG | — |
| Epic Pharma Llc | For profit | NDA2 | Nov 27, 1991 |
| Esteve Labs | For profit | SYN | Mar 8, 2017 |
| Esteve Labs | For profit | MKTG | Mar 8, 2017 |
| Eugia Pharma | For profit | MKTG | Jan 30, 2020 |
| Eugia Pharma | For profit | SYN | Mar 29, 2012 |
| Exela Pharma Sciences, LLC. | For profit | MKTG | Jun 20, 2019 |
| Exela Pharma Sciences, LLC. | For profit | SYN | Jun 20, 2019 |
| Fresenius | For profit | MKTG | Feb 26, 1999 |
| Goldline | For profit | MKTG | Dec 23, 1988 |
| Guardian Drug | For profit | MKTG | Apr 30, 2020 |
| Henry Schein, Inc | For profit | NDA2 | Jul 26, 2006 |
| Hikma | For profit | MKTG | Aug 1, 1994 |
| Hikma | For profit | SYN | Sep 16, 1986 |
| Hospira | For profit | SYN | Apr 30, 1986 |
| Hospira | For profit | SYN | Mar 4, 2016 |
| Hospira | For profit | NDA2 | Apr 30, 1986 |
| Hospira | For profit | MKTG | Nov 9, 2005 |
| International Medication | For profit | MKTG | Sep 19, 2017 |
| Lotus Pharmaceutical | For profit | MKTG | Apr 23, 2021 |
| Lukare Medical | For profit | MKTG | Sep 27, 1996 |
| Lukare Medical | For profit | NDA2 | Sep 27, 1996 |
| Mallinckrodt | For profit | MKTG | Aug 7, 1985 |
| Mylan | For profit | MKTG | Jan 28, 2010 |
| Mylan | For profit | SYN | Feb 5, 2004 |
| Mylan | For profit | SYN | Oct 26, 1984 |
| Mylan | For profit | SYN | Mar 29, 2012 |
| Mylan | For profit | NDA2 | Oct 26, 1984 |
| Nestle | For profit | NDA2 | Oct 28, 1981 |
| Nestle | For profit | NDA | Oct 28, 1981 |
| Norbrook | For profit | MKTG | May 9, 1986 |
| Nostrum Laboratories | For profit | MKTG | Mar 8, 2017 |
| Novel Anti-Infective Technologies, LLC | For profit | MKTG | May 27, 2009 |
| OMNIVIUM PHARMS | For profit | MKTG | Jun 15, 2023 |
| Paddock Laboratories | For profit | MKTG | Feb 25, 2010 |
| Par Pharmaceuticals | For profit | MKTG | May 25, 2010 |
| Perrigo | For profit | MKTG | Jul 15, 2016 |
| Perrigo | For profit | SYN | Feb 25, 2010 |
| Pfizer | For profit | MKTG | Mar 4, 2016 |
| Pharmachemie Bv | For profit | MKTG | Jan 8, 2010 |
| Pharmachemie Bv | For profit | SYN | Jul 8, 1988 |
| Pharmacia & Upjohn | For profit | MKTG | Aug 23, 1991 |
| RILEY CONSUMER | For profit | NDA2 | Dec 1, 2009 |
| STERISCIENCE | For profit | MKTG | Jun 28, 2023 |
| Sagent Pharmaceuticals, Inc. | For profit | MKTG | Aug 9, 2018 |
| Salix | For profit | NDA2 | Jun 15, 2004 |
| Sandoz | For profit | MKTG | Mar 31, 2009 |
| Sandoz | For profit | SYN | Mar 31, 2009 |
| Santarus | For profit | MKTG | Dec 21, 2004 |
| Santarus | For profit | SYN | Jun 15, 2004 |
| Santarus | For profit | NDA2 | Dec 21, 2004 |
| Sciegen Pharmaceticals | For profit | MKTG | Dec 6, 2016 |
| Silvergate Pharmaceuticals | For profit | MKTG | Apr 25, 2017 |
| Strides Pharma Science | For profit | MKTG | Apr 13, 2015 |
| Sun Pharmaceuticals | For profit | MKTG | May 21, 2015 |
| Unicorn Pacific Corporation | For profit | MKTG | Jul 15, 2016 |
| Vintage | For profit | MKTG | Jan 28, 1992 |
| Watson Pharmaceuticals | For profit | NDA2 | Jul 26, 2006 |
| West-Ward Pharmaceutical | For profit | MKTG | Sep 16, 1986 |
| Zydus Discovery DMCC | For profit | MKTG | Mar 16, 2018 |
| Zydus Discovery DMCC | For profit | SYN | Mar 16, 2018 |