Active ingredient
Sodium Acetate
25 finished FDA listings contain Sodium Acetate as their only active ingredient; 39 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- SODIUM ACETATE, SODIUM ACETATE ANHYDROUS
- Dosage forms
- Injection, Injection, Solution, Concentrate, Pellet, Solution, Concentrate
- Routes
- Intravenous, Oral
- Manufacturers / labelers
- 7
- Strengths listed
- 1 [hp_m]/1 · 1 [hp_q]/1 · 100 [hp_c]/1 · 12 [hp_c]/1 · 164 mg/ml · 200 [hp_c]/1 · 200 meq/100ml · 3.28 g/20ml · 30 [hp_c]/1 · 4 meq/100ml · 400 meq/100ml · 500 [hp_c]/1 · 6 [hp_c]/1
- Brand names in FDA listings
- Sodium Acetate
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 56443
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 |
|---|---|---|---|
| NDA 018893 | HOSPIRA | 1983-05-04 | 4 |
| ANDA 206687 | FRESENIUS KABI USA | 2017-10-30 | 1 |
| ANDA 214805 | MILLA PHARMS | 2021-05-04 | 4 |
| ANDA 216920 | HIKMA | 2024-03-15 | 3 |
| ANDA 218469 | AMNEAL | 2025-08-08 | 3 |
| ANDA 219826 | SOMERSET THERAPS LLC | 2025-09-18 | 2 |
Official labeling on DailyMed
- SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [AMNEAL PHARMACEUTICALS PRIVATE LIMITED] · version 4 · 2026-08-24
- SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] · version 11 · 2026-03-30
- SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] · version 12 · 2026-03-30
- SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] · version 15 · 2026-03-30
- SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] · version 19 · 2026-03-30
- SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE SODIUM ACETATE (SODIUM ACETATE INJECTION, USP, 200 MEQ/100 ML) INJECTION, SOLUTION, CONCENTRATE SODIUM ACETATE (SODIUM ACETATE INJECTION, USP, 400 MEQ/100 ML) INJECTION, SOLUTION, CONCENTRATE [MILLA PHARMACEUTICALS INC.] · version 4 · 2026-01-09
- SODIUM ACETATE ANHYDROUS SOLUTION, CONCENTRATE [SOMERSET THERAPEUTICS, LLC] · version 4 · 2025-11-17
- SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [AMNEAL PHARMACEUTICALS PRIVATE LIMITED] · version 3 · 2025-08-13
- SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [MILLA PHARMACEUTICALS INC.] · version 3 · 2025-01-20
- SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [FRESENIUS KABI USA, LLC] · version 6 · 2024-10-17
- SODIUM ACETATE INJECTION [HIKMA PHARMACEUTICALS USA INC.] · version 1 · 2024-05-20
- SODIUM ACETATE INJECTION [HIKMA PHARMACEUTICALS USA INC.] · version 1 · 2024-05-20
Showing the 12 most recent of 13 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.