Zinc Sulfate
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZINC SULFATE INJECTION safely and effectively. See full prescribing information for ZINC SULFATE INJECTION. ZINC SULFATE injection, for intravenous use. Initial U.S. Approval: 1957
Approved
Approval ID
dfa8a859-c285-17a3-e053-2a95a90a9343
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2023
Manufacturers
FDA
Piramal Critical Care Inc.
DUNS: 805600439
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Zinc Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66794-239
Application NumberANDA216249
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zinc Sulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 21, 2023
FDA Product Classification
INGREDIENTS (3)
ZINC SULFATEActive
Quantity: 25 mg in 5 mL
Code: 89DS0H96TB
Classification: ACTIB
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Zinc Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66794-240
Application NumberANDA216249
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zinc Sulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 21, 2023
FDA Product Classification
INGREDIENTS (3)
ZINC SULFATEActive
Quantity: 30 mg in 10 mL
Code: 89DS0H96TB
Classification: ACTIB
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT