DailyMed - ZINC SULFATE injection, solution

NDC Code(s): 70771-1848-1, 70771-1848-7, 70771-1849-1, 70771-1849-7, view more
70771-1850-1, 70771-1850-7
Packager: Zydus Lifesciences Limited

Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 31, 2023

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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 ...

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

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INGREDIENTS AND APPEARANCE

Product Information

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)

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	RxCUI	RxNorm NAME	RxTTY
1	2201521	zinc sulfate 3 MG/ML Injectable Solution	PSN
2	2201521	zinc sulfate 3 MG/ML Injectable Solution	SCD
3	2201521	ZnSO4 3 MG/ML Injectable Solution	SY
4	2201524	zinc sulfate 5 MG/ML Injectable Solution	PSN
5	2201524	zinc sulfate 5 MG/ML Injectable Solution	SCD
6	2201524	ZnSO4 5 MG/ML Injectable Solution	SY
7	2369390	zinc sulfate 1 MG in ML Injectable Solution	PSN
8	2369390	zinc sulfate 1 MG/ML Injectable Solution	SCD
9	2369390	ZnSO4 1 MG/ML Injectable Solution	SY

Label: ZINC SULFATE injection, solution

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	NDC
1	70771-1848-1
2	70771-1848-7
3	70771-1849-1
4	70771-1849-7
5	70771-1850-1
6	70771-1850-7

Label: ZINC SULFATE injection, solution

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Drug Label Info

Safety

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More Info For This Drug

Drug Label Information

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More Info on this Drug

ZINC SULFATE injection, solution

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ZINC SULFATE injection, solution

ZINC SULFATE injection, solution

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ZINC SULFATE injection, solution

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.