zinc sulfate

Generic: zinc sulfate

Labeler: american regent, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zinc sulfate
Generic Name zinc sulfate
Labeler american regent, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

zinc sulfate 3 mg/mL

Manufacturer
American Regent, Inc.

Identifiers & Regulatory

Product NDC 0517-6103
Product ID 0517-6103_daf09709-3280-43f1-9db6-e5dbad4c060b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209377
Listing Expiration 2026-12-31
Marketing Start 2019-10-01

Pharmacologic Class

Classes
copper absorption inhibitor [epc] decreased copper ion absorption [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05176103
Hyphenated Format 0517-6103

Supplemental Identifiers

RxCUI
2201521 2201524 2369390
UPC
0305176101255 0305176510255
UNII
89DS0H96TB

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zinc sulfate (source: ndc)
Generic Name zinc sulfate (source: ndc)
Application Number NDA209377 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 TRAY (0517-6103-25) / 10 mL in 1 VIAL (0517-6103-01)
source: ndc

Packages (1)

0517-6103-25 25 VIAL in 1 TRAY (0517-6103-25) / 10 mL in 1 VIAL (0517-6103-01)

Ingredients (1)

zinc sulfate (3 mg/mL)

Linked Drug Pages (1)

Zinc Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "daf09709-3280-43f1-9db6-e5dbad4c060b", "openfda": {"upc": ["0305176101255", "0305176510255"], "unii": ["89DS0H96TB"], "rxcui": ["2201521", "2201524", "2369390"], "spl_set_id": ["4b528c88-07a0-4dce-84c6-ccd32555bbff"], "manufacturer_name": ["American Regent, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 TRAY (0517-6103-25)  / 10 mL in 1 VIAL (0517-6103-01)", "package_ndc": "0517-6103-25", "marketing_start_date": "20191001"}], "brand_name": "Zinc Sulfate", "product_id": "0517-6103_daf09709-3280-43f1-9db6-e5dbad4c060b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "0517-6103", "generic_name": "Zinc Sulfate", "labeler_name": "American Regent, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zinc Sulfate", "active_ingredients": [{"name": "ZINC SULFATE", "strength": "3 mg/mL"}], "application_number": "NDA209377", "marketing_category": "NDA", "marketing_start_date": "20191001", "listing_expiration_date": "20261231"}