Active ingredient
Nitroprusside
22 finished FDA listings contain Nitroprusside as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- SODIUM NITROPRUSSIDE
- Dosage forms
- Injection, Injection, Solution, Injection, Solution, Concentrate
- Routes
- Intravenous
- Manufacturers / labelers
- 13
- Strengths listed
- .2 mg/ml · .5 mg/ml · 25 mg/ml · 50 mg/2ml
- Brand names in FDA listings
- Nipride Rtu
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 7476
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 209387 | EXELA PHARMA | 2017-03-08 | 2 |
| ANDA 209493 | AMNEAL | 2017-11-07 | 1 |
| ANDA 209352 | MICRO LABS | 2017-12-08 | 2 |
| ANDA 210763 | MYLAN LABS LTD | 2018-04-17 | 2 |
| ANDA 210882 | SOMERSET THERAPS LLC | 2018-08-17 | 1 |
| ANDA 210114 | DR REDDYS | 2019-04-10 | 2 |
| ANDA 211016 | CAPLIN | 2019-11-29 | 2 |
| ANDA 214199 | HAINAN POLY | 2020-08-25 | 2 |
| ANDA 211934 | EUGIA PHARMA | 2020-12-10 | 1 |
| ANDA 214971 | BE PHARMS | 2021-07-12 | 1 |
| ANDA 215846 | HAINAN POLY | 2022-08-26 | 6 |
Official labeling on DailyMed
- SODIUM NITROPRUSSIDE (SODIUM NITROPRUSSIDE) INJECTION [MICRO LABS LIMITED] · version 7 · 2026-08-11
- SODIUM NITROPRUSSIDE INJECTION, SOLUTION, CONCENTRATE [MYLAN INSTITUTIONAL LLC] · version 5 · 2026-07-02
- SODIUM NITROPRUSSIDE INJECTION, SOLUTION, CONCENTRATE [SOMERSET THERAPEUTICS, LLC] · version 10 · 2026-06-26
- SODIUM NITROPRUSSIDE INJECTION, SOLUTION [DR.REDDY'S LABORATORIES INC.,] · version 1 · 2025-12-02
- SODIUM NITROPRUSSIDE INJECTION [CAPLIN STERILES LIMITED] · version 4 · 2025-11-17
- SODIUM NITROPRUSSIDE INJECTION, SOLUTION, CONCENTRATE [MYLAN INSTITUTIONAL LLC] · version 2 · 2025-11-17
- SODIUM NITROPRUSSIDE INJECTION, SOLUTION [DR.REDDY'S LABORATORIES INC.,] · version 4 · 2024-12-23
- SODIUM NITROPRUSSIDE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] · version 2 · 2024-12-06
- SODIUM NITROPRUSSIDE INJECTION, SOLUTION, CONCENTRATE [HAINAN POLY PHARM. CO., LTD.] · version 1 · 2024-08-14
- SODIUM NITROPRUSSIDE INJECTION [AMNEAL PHARMACEUTICALS LLC] · version 10 · 2024-08-08
- SODIUM NITROPRUSSIDE IN 0.9% SODIUM CHLORIDE INJECTION [SLATE RUN PHARMACEUTICALS, LLC] · version 2 · 2023-11-14
- SODIUM NITROPRUSSIDE (SODIUM NITROPRUSSIDE) INJECTION [ARMAS PHARMACEUTICALS INC.] · version 4 · 2023-08-01
Showing the 12 most recent of 17 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.