Quick answers
- What is Zinc sulfate used for?
- The FDA-approved label (Zinc Sulfate, American Regent, Inc., October 1, 2020) says: “Zinc Sulfate Injection is 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. Zinc Sulfate Injection is a trace element 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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Zinc sulfate have a boxed warning?
- No. None of the 9 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Zinc sulfate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Zinc sulfate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Zinc sulfate?
- 8 companies list prescription products of Zinc sulfate in the FDA NDC Directory, including American Regent, Inc., Fresenius Kabi USA, LLC and Gland Pharma Limited.
What Zinc sulfate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Zinc Sulfate Injection is 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. Zinc Sulfate Injection is a trace element 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.
— FDA label: Zinc Sulfate, American Regent, Inc., effective October 1, 2020. Read the full label on DailyMed →
The FDA has 9 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 9 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Solution |
|---|---|
| Route | Intravenous |
| Prescription products | 23 in the FDA NDC Directory |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- American Regent, Inc.3 products
- Fresenius Kabi USA, LLC3 products
- Gland Pharma Limited3 products
- Zydus Pharmaceuticals USA Inc.3 products
- Zydus Lifesciences Limited3 products
- Piramal Critical Care Inc3 products
- Camber Pharmaceuticals, Inc.3 products
- Somerset Therapeutics, LLC2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA209377 ZINC SULFATE | Am Regent | July 18, 2019 | 1, latest October 28, 2020 2020: Labeling |
Generic approvals (5)
- ANDA216249Gland · May 3, 2022
- ANDA216145Fresenius Kabi USA · December 27, 2022
- ANDA217074Zydus Pharms · August 22, 2023
- ANDA216135Somerset Theraps LLC · July 17, 2024
- ANDA219585Aspiro · May 1, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2201521, 2201524, 2369390 |
|---|---|
| SPL set ID of the quoted label | 4b528c88-07a0-4dce-84c6-ccd32555bbff |
| FDA labels (SPL) | 9 |
| FDA applications | NDA209377, 5 ANDA |
| Active ingredients (FDA) | ZINC SULFATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Zinc Sulfate, American Regent, Inc., effective October 1, 2020; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →