NDC 0517-8005

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 ID: 0517-8005_4a790327-f9d3-46ba-81e8-00404631dbbf
• NDC: 0517-8005
• Product Type: Human Prescription Drug
• Proprietary Name: Zinc Sulfate
• Generic Name: Zinc Sulfate
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-10-01
• Marketing Category: NDA / NDA
• Application Number: NDA209377
• Labeler Name: American Regent, Inc.
• Substance Name: ZINC SULFATE
• Active Ingredient Strength: 5 mg/mL
• Pharm Classes: Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0517-8005-25

25 VIAL in 1 TRAY (0517-8005-25) > 5 mL in 1 VIAL (0517-8005-01)

• Marketing Start Date: 2019-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0517-8005-01 [00517800501]

Zinc Sulfate INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA209377
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-10-01

NDC 0517-8005-25 [00517800525]

Zinc Sulfate INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA209377
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-10-01

Drug Details

Active Ingredients

Ingredient	Strength
ZINC SULFATE	5 mg/mL

OpenFDA Data

• SPL SET ID: 4b528c88-07a0-4dce-84c6-ccd32555bbff
• Manufacturer:
  • American Regent, Inc.
• UNII:
  • 89DS0H96TB
• 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"

NDC	Brand Name	Generic Name
0517-6101	Zinc Sulfate	Zinc Sulfate
0517-6103	Zinc Sulfate	Zinc Sulfate
0517-6110	Zinc Sulfate	Zinc Sulfate
0517-8005	Zinc Sulfate	Zinc Sulfate
0517-8105	Zinc Sulfate	Zinc Sulfate
65219-401	Zinc Sulfate	Zinc Sulfate
65219-403	Zinc Sulfate	Zinc Sulfate
65219-405	Zinc Sulfate	Zinc Sulfate
66794-239	Zinc Sulfate	Zinc Sulfate
66794-240	Zinc Sulfate	Zinc Sulfate
68083-498	Zinc Sulfate	Zinc Sulfate
68083-499	Zinc Sulfate	Zinc Sulfate