zinc sulfate
These highlights do not include all the information needed to use ZINC SULFATEINJECTION 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
95aa8437-10bc-4205-939f-d21d8fa52a00
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2023
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
zinc sulfate injection,
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70710-1878
Application NumberANDA217074
Product Classification
M
Marketing Category
C73584
G
Generic Name
zinc sulfate injection,
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 31, 2023
FDA Product Classification
INGREDIENTS (3)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ZINC SULFATEActive
Quantity: 5 mg in 1 mL
Code: 89DS0H96TB
Classification: ACTIB
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
zinc sulfate injection,
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70710-1877
Application NumberANDA217074
Product Classification
M
Marketing Category
C73584
G
Generic Name
zinc sulfate injection,
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 31, 2023
FDA Product Classification
INGREDIENTS (3)
ZINC SULFATEActive
Quantity: 3 mg in 1 mL
Code: 89DS0H96TB
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
zinc sulfate injection,
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70710-1876
Application NumberANDA217074
Product Classification
M
Marketing Category
C73584
G
Generic Name
zinc sulfate injection,
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 31, 2023
FDA Product Classification
INGREDIENTS (3)
ZINC SULFATEActive
Quantity: 1 mg in 1 mL
Code: 89DS0H96TB
Classification: ACTIB
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT