Label: ZINC SULFATE injection, solution
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NDC Code(s):
70771-1848-1,
70771-1848-7,
70771-1849-1,
70771-1849-7, view more70771-1850-1, 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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- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
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
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
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
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
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
ZINC SULFATE
zinc sulfate injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1848 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC SULFATE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength SULFURIC ACID (UNII: O40UQP6WCF) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA217074 12/07/2023 ZINC SULFATE
zinc sulfate injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1849 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC SULFATE 3 mg in 1 mL Inactive Ingredients Ingredient Name Strength SULFURIC ACID (UNII: O40UQP6WCF) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA217074 12/07/2023 ZINC SULFATE
zinc sulfate injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1850 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC SULFATE 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength SULFURIC ACID (UNII: O40UQP6WCF) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA217074 12/07/2023 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 873671928 MANUFACTURE(70771-1848, 70771-1849, 70771-1850) , ANALYSIS(70771-1848, 70771-1849, 70771-1850)