PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1848-1

Zinc Sulfate Injection, USP

10 mg/10 mL (1 mg/mL) of zinc

For intravenous use after dilution and admixing

PHARMACY BULK PACKAGE-Not for Direct Infusion

STERILE

10 mL

Rx only

NDC 70771-1848-7

Zinc Sulfate Injection, USP

10 mg/10 mL (1 mg/mL) of zinc

For intravenous use after dilution and admixing

PHARMACY BULK PACKAGE-Not for Direct Infusion

25 x 10 mL Vials

STERILE

10 mL

Rx only

NDC 70771-1849-1

Zinc Sulfate Injection, USP

30 mg/10 mL (3 mg/mL) of zinc

For intravenous use after dilution and admixing

PHARMACY BULK PACKAGE-Not for Direct Infusion

STERILE

10 mL

Rx only

NDC 70771-1849-7

Zinc Sulfate Injection, USP

30 mg/10 mL (3 mg/mL) of zinc

For intravenous use after dilution and admixing

PHARMACY BULK PACKAGE-Not for Direct Infusion

25 X 10 mL Vials

STERILE

10 mL

Rx only

NDC 70771-1850-1

Zinc Sulfate Injection, USP

25 mg/5 mL (5 mg/mL) of zinc

For intravenous use after dilution and admixing

PHARMACY BULK PACKAGE-Not for Direct Infusion

STERILE

5 mL

Rx only

NDC 70771-1850-7

Zinc Sulfate Injection, USP

25 mg/5 mL (5 mg/mL) of zinc

For intravenous use after dilution and admixing

PHARMACY BULK PACKAGE-Not for Direct Infusion

25 X 5 mL Vials

STERILE

5 mL

Rx only

ZINC SULFATE
zinc sulfate injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1848
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37)	ZINC SULFATE	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SULFURIC ACID (UNII: O40UQP6WCF)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1848-7	25 in 1 CARTON	12/07/2023
1	NDC:70771-1848-1	10 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA217074	12/07/2023

ZINC SULFATE
zinc sulfate injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1849
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37)	ZINC SULFATE	3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SULFURIC ACID (UNII: O40UQP6WCF)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1849-7	25 in 1 CARTON	12/07/2023
1	NDC:70771-1849-1	10 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA217074	12/07/2023

ZINC SULFATE
zinc sulfate injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1850
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37)	ZINC SULFATE	5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SULFURIC ACID (UNII: O40UQP6WCF)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1850-7	25 in 1 CARTON	12/07/2023
1	NDC:70771-1850-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA217074	12/07/2023

Labeler - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		873671928	MANUFACTURE(70771-1848, 70771-1849, 70771-1850) , ANALYSIS(70771-1848, 70771-1849, 70771-1850)

ZINC SULFATE INJECTION for intravenous use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL