NDC 0517-6103

Zinc Sulfate

Zinc Sulfate

Zinc Sulfate is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by American Regent, Inc.. The primary component is Zinc Sulfate.

Product ID0517-6103_4a790327-f9d3-46ba-81e8-00404631dbbf
NDC0517-6103
Product TypeHuman Prescription Drug
Proprietary NameZinc Sulfate
Generic NameZinc Sulfate
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-10-01
Marketing CategoryNDA / NDA
Application NumberNDA209377
Labeler NameAmerican Regent, Inc.
Substance NameZINC SULFATE
Active Ingredient Strength3 mg/mL
Pharm ClassesCopper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0517-6103-25

25 VIAL in 1 TRAY (0517-6103-25) > 10 mL in 1 VIAL (0517-6103-01)
Marketing Start Date2019-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0517-6103-01 [00517610301]

Zinc Sulfate INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA209377
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-10-01

NDC 0517-6103-25 [00517610325]

Zinc Sulfate INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA209377
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-10-01

Drug Details

Active Ingredients

IngredientStrength
ZINC SULFATE3 mg/mL

OpenFDA Data

SPL SET ID:4b528c88-07a0-4dce-84c6-ccd32555bbff
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2201521
  • 2201524
  • UPC Code
  • 0305176510255
  • Pharmacological Class

    • Copper Absorption Inhibitor [EPC]
    • Decreased Copper Ion Absorption [PE]

    NDC Crossover Matching brand name "Zinc Sulfate" or generic name "Zinc Sulfate"

    NDCBrand NameGeneric Name
    0517-6101Zinc SulfateZinc Sulfate
    0517-6103Zinc SulfateZinc Sulfate
    0517-6110Zinc SulfateZinc Sulfate
    0517-8005Zinc SulfateZinc Sulfate
    0517-8105Zinc SulfateZinc Sulfate
    65219-401Zinc SulfateZinc Sulfate
    65219-403Zinc SulfateZinc Sulfate
    65219-405Zinc SulfateZinc Sulfate
    66794-239Zinc SulfateZinc Sulfate
    66794-240Zinc SulfateZinc Sulfate
    68083-498Zinc SulfateZinc Sulfate
    68083-499Zinc SulfateZinc Sulfate

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