Active ingredient
Sodium Bicarbonate
103 finished FDA listings contain Sodium Bicarbonate as their only active ingredient; 146 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- SODIUM BICARBONATE
- Dosage forms
- Cloth, Cream, Gel, Injection, Injection, Solution, Liquid, Lotion, Powder, Solution, Solution, Concentrate, Tablet, Tablet, Soluble
- Routes
- Hemodialysis, Intramuscular, Intravenous, Oral, Topical
- Manufacturers / labelers
- 61
- Strengths listed
- .05 g/1 · .7 g/14g · .7 u/100u · 1 g/g · 1.04 g/20g · 1000 mg/g · 12.6 mg/ml · 2.6 g/2.6g · 2.616 g/2.616g · 25 mg/ml · 315 mg/g · 325 mg/1 · 42 mg/ml · 5 g/100g · 5 g/100ml · 5 g/25g · 50 mg/1000ml · 525 mg/15ml · 6 [hp_x]/6[hp_x] · 6 [hp_x]/60mg · 616 mg/g · 648 mg/1 · 650 mg/1 · 75 mg/ml · 8.4 g/100ml · 84 mg/ml
- Brand names in FDA listings
- Adrian Bicarbonato Sodium Bicarbonate Usp-4 Oz, 8 Oz And 16 Oz, After Bite Advanced, After Bite Kids, After Bite X Tech, Ahhh Bite Relief, Anti-Empacho, Arm And Hammer Baking Soda, Bestmade Natural Products Sodium Bicarbonate (Nat Bicarb), Bm Sodium Bicarbonate (Nat Bicarb), D-D Sudium Bicarbonate U.s.p. Bicarbonato De Soda Puro, De La Cruz Desempacho, De La Cruz Sodium Bicarbonate Antacid, Dermfree Insect Bite Relief, Dr. Sana Bicarbonato De Sodio 4 Fl Oz And 6 Floz, Ecodent Ultimate Essential Mouthcare Sparkling Clean Mint, Ecodent Ultimate Essential Mouthcare Spicy-Cool Cinnamon, Humco Sodium Bicarbonate, Insect Sting Relief Latex 01, Insect Sting Relief Pad 01, Itch Eraser Sensitive, Medis Sodium Bicarbonate, Quabic-100, Quabic-300, Rapidol Sodium Bicarbonate, Sanar Baking Soda 8oz 100% Pure, Sodium Bicarbonate, Sodium Bicarbonate 10 Gr, Sodium Bicarbonate 10 Gr (650 Mg), Sodium Bicarbonate 10 Gr. (650 Mg), Sodium Bicarbonate 5 Gr, Sodium Bicarbonate 5 Gr (325 Mg), Sodium Bicarbonate Antacid
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 36676
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 202981 | HOSPIRA | 2016-03-04 | 4 |
| ANDA 202494 | HOSPIRA | 2017-03-06 | 2 |
| ANDA 203449 | INTL MEDICATION SYS | 2017-09-19 | 5 |
| ANDA 202432 | HOSPIRA | 2017-09-26 | 4 |
| ANDA 211091 | EXELA PHARMA | 2019-06-20 | 9 |
| ANDA 216364 | OMNIVIUM PHARMS | 2023-06-15 | 2 |
| ANDA 217594 | STERISCIENCE | 2023-06-28 | 4 |
| ANDA 216042 | LONG GROVE PHARMS | 2024-02-27 | 2 |
| ANDA 219701 | ADAPTIS | 2025-06-26 | 3 |
| ANDA 206688 | FRESENIUS KABI USA | 2025-08-25 | 2 |
| ANDA 217523 | AMNEAL | 2026-01-13 | 1 |
| ANDA 219089 | MILLA PHARMS | 2026-07-06 | 1 |
| NDA 220790 | AMNEAL | 2026-07-09 | 1 |
| NDA 218524 | BAXTER HLTHCARE CORP | 2026-08-14 | 1 |
Official labeling on DailyMed
- SODIUM BICARBONATE INJECTION [REMEDYREPACK INC.] · version 5 · 2026-08-31
- SODIUM BICARBONATE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] · version 1 · 2026-08-28
- SODIUM BICARBONATE POWDER [VITAMEX USA, CORP] · version 1 · 2026-08-28
- SODIUM BICARBONATE INJECTION, SOLUTION [EXELA PHARMA SCIENCES, LLC] · version 1 · 2026-08-26
- ARM AND HAMMER BAKING SODA (SODIUM BICARBONATE) POWDER [CHURCH & DWIGHT CO., INC.] · version 9 · 2026-08-24
- SODIUM BICARBONATE (SODIUM BICARBONATE, INJECTION) SOLUTION [CIVICA, INC.] · version 2 · 2026-08-11
- SODIUM BICARBONATE INJECTION, SOLUTION [MILLA PHARMACEUTICALS INC.] · version 3 · 2026-08-10
- SODIUM BICARBONATE 5 GR (SODIUM BICARBONATE) TABLET [TWIN MED LLC] · version 8 · 2026-08-05
- DERMFREE INSECT BITE RELIEF (SODIUM BICARBONATE 5% INSECT BITE RELIEF) LIQUID [WENZHOU YUYUAN PHARMACEUTICAL CO., LTD.] · version 1 · 2026-07-28
- SODIUM BICARBONATE INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS PRIVATE LIMITED] · version 7 · 2026-07-14
- SODIUM BICARBONATE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] · version 4 · 2026-06-30
- SODIUM BICARBONATE TABLET [CARDINAL HEALTH 107, LLC] · version 5 · 2026-06-22
Showing the 12 most recent of 96 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.