Zinc Sulfate
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
4b528c88-07a0-4dce-84c6-ccd32555bbff
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2020
Manufacturers
FDA
American Regent, Inc.
DUNS: 002033710
Products 3
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 Code0517-8005
Application NumberNDA209377
Product Classification
M
Marketing Category
C73594
G
Generic Name
Zinc Sulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 1, 2020
FDA Product Classification
INGREDIENTS (3)
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ZINC SULFATEActive
Quantity: 5 mg in 1 mL
Code: 89DS0H96TB
Classification: ACTIM
Zinc Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0517-6103
Application NumberNDA209377
Product Classification
M
Marketing Category
C73594
G
Generic Name
Zinc Sulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 1, 2020
FDA Product Classification
INGREDIENTS (3)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ZINC SULFATEActive
Quantity: 3 mg in 1 mL
Code: 89DS0H96TB
Classification: ACTIM
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
Zinc Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0517-6101
Application NumberNDA209377
Product Classification
M
Marketing Category
C73594
G
Generic Name
Zinc Sulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 1, 2020
FDA Product Classification
INGREDIENTS (3)
ZINC SULFATEActive
Quantity: 1 mg in 1 mL
Code: 89DS0H96TB
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT