Medicine
Zinc sulfate 25 mg/5 mL injection
Zinc sulfate 25 mg/5 mL injection is a generic prescription medicine for intravenous use, made by 7 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Zinc sulfate
- Brand
- Sold under the generic name
- Strength
- 25 mg/5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 25 vials of 5 mL and 5 more
- Manufacturers
- Zydus LifesciencesIndiaCamber PharmaceuticalsIndiaGland PharmaIndiaPiramal Critical CareIndiaAmerican RegentFresenius KabiSomerset Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). For storage of admixed solution see Dosage and Administration.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A12CB01 Zinc sulfate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 October 2019
- Identifiers
- RxCUI 2201521, 2201524, 2369390DailyMed set ID 37d54dcd-b720-4168-bfb2-c8f381466aac, dfa8a859-c285-17a3-e053-2a95a90a9343, c9d45d0e-a165-4112-81f9-c0e455572ecf +5NDC 65219-405, 66794-239, 70069-691 +5Application ANDA216145, ANDA216249, ANDA216135 +3
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 25 vial in 1 carton / 5 mL in 1 vial | 70710-1878-7 | Zydus LifesciencesIndia | 7 December 2023 |
| 25 vial in 1 carton / 5 mL in 1 vial | 70771-1850-7 | Zydus LifesciencesIndia | 7 December 2023 |
| 25 vial in 1 carton / 5 mL in 1 vial | 31722-455-31 | Camber PharmaceuticalsIndia | 1 May 2025 |
| 25 vial in 1 carton / 5 mL in 1 vial | 68083-499-25 | Gland PharmaIndia | 3 May 2022 |
| 25 vial in 1 carton / 5 mL in 1 vial | 66794-239-42 | Piramal Critical CareIndia | 20 June 2022 |
| 25 vial in 1 tray / 5 mL in 1 vial | 0517-8005-25 | American Regent | 1 October 2019 |
| 25 vial in 1 tray / 5 mL in 1 vial | 65219-405-05 | Fresenius Kabi | 27 December 2022 |
| 25 vial in 1 carton / 5 mL in 1 vial | 70069-691-25 | Somerset Therapeutics | 18 July 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 5 May 1987 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Zinc sulfate
Clinical summary
Zinc sulfate is a copper absorption inhibitor indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. MedsAcross supplies Zinc sulfate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Zinc sulfateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Zinc Sulfate prescribing information (American Regent) · U.S. National Library of Medicine, DailyMed
Need Zinc sulfate 25 mg/5 mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.