Active ingredient
Zinc Sulfate
36 finished FDA listings contain Zinc Sulfate as their only active ingredient; 39 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- ZINC SULFATE, ZINC SULFATE ANHYDROUS, ZINC SULFATE HEPTAHYDRATE, ZINC SULFATE MONOHYDRATE, ZINC SULFATE, UNSPECIFIED FORM
- Dosage forms
- Injection, Injection, Solution, Pellet, Solution
- Routes
- Intravenous, Oral
- Manufacturers / labelers
- 11
- Strengths listed
- 1 [hp_m]/1 · 1 [hp_q]/1 · 1 mg/ml · 10 [hp_m]/1 · 100 [hp_c]/1 · 12 [hp_c]/1 · 200 [hp_c]/1 · 200 [kp_c]/200[kp_c] · 25 mg/5ml · 3 mg/ml · 30 [hp_c]/1 · 30 [hp_c]/30[hp_c] · 30 mg/10ml · 5 mg/ml · 500 [hp_c]/1 · 6 [hp_c]/1
- Brand names in FDA listings
- Zinc Sulfate, Zincum Sulphuricum
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 39954
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 209377 | AM REGENT | 2019-07-18 | 3 |
| ANDA 216249 | GLAND | 2022-05-03 | 6 |
| ANDA 216145 | FRESENIUS KABI USA | 2022-12-27 | 3 |
| ANDA 217074 | ZYDUS PHARMS | 2023-08-22 | 6 |
| ANDA 218059 | APOTEX | 2024-06-10 | 2 |
| ANDA 216135 | SOMERSET THERAPS LLC | 2024-07-17 | 2 |
| ANDA 219585 | ASPIRO | 2025-05-01 | 3 |
Official labeling on DailyMed
- ZINC SULFATE (ZINC SULFATE) INJECTION, SOLUTION [CAMBER PHARMACEUTICALS, INC.] · version 2 · 2026-03-05
- ZINC SULFATE INJECTION, SOLUTION [PIRAMAL CRITICAL CARE INC.] · version 5 · 2025-11-17
- ZINC SULFATE INJECTION, SOLUTION [PIRAMAL CRITICAL CARE INC.] · version 3 · 2024-12-20
- ZINC SULFATE (ZINC SULFATE INJECTION,) SOLUTION [ZYDUS PHARMACEUTICALS USA INC.] · version 2 · 2024-12-09
- ZINCUM SULPHURICUM (ZINC SULFATE HEPTAHYDRATE) PELLET [BOIRON] · version 1 · 2024-09-10
- ZINC SULFATE SOLUTION [SOMERSET THERAPEUTICS, LLC] · version 3 · 2024-07-19
- ZINC SULFATE INJECTION, SOLUTION [AMERICAN REGENT, INC.] · version 8 · 2024-01-23
- ZINC SULFATE INJECTION, SOLUTION [ZYDUS LIFESCIENCES LIMITED] · version 1 · 2023-12-07
- ZINCUM SULPHURICUM (ZINC SULFATE HEPTAHYDRATE) PELLET [BOIRON] · version 2 · 2023-11-16
- ZINC SULFATE INJECTION, SOLUTION [GLAND PHARMA LIMITED] · version 5 · 2023-09-21
- ZINCUM SULPHURICUM PELLET [HAHNEMANN LABORATORIES, INC.] · version 1 · 2023-07-18
- ZINC SULFATE (ZINC SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC · version 1 · 2023-01-10
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.