zinc sulfate

Generic: zinc sulfate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zinc sulfate
Generic Name zinc sulfate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

zinc sulfate 3 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-403
Product ID 65219-403_af258d83-398d-4601-ab09-14c9fe383cc2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216145
Listing Expiration 2026-12-31
Marketing Start 2022-12-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219403
Hyphenated Format 65219-403

Supplemental Identifiers

RxCUI
2201521 2201524 2369390
UPC
0365219403012 0365219401001 0365219405023
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 ANDA216145 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 TRAY (65219-403-03) / 10 mL in 1 VIAL (65219-403-01)
source: ndc

Packages (1)

65219-403-03 25 VIAL in 1 TRAY (65219-403-03) / 10 mL in 1 VIAL (65219-403-01)

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": "af258d83-398d-4601-ab09-14c9fe383cc2", "openfda": {"upc": ["0365219403012", "0365219401001", "0365219405023"], "unii": ["89DS0H96TB"], "rxcui": ["2201521", "2201524", "2369390"], "spl_set_id": ["37d54dcd-b720-4168-bfb2-c8f381466aac"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 TRAY (65219-403-03)  / 10 mL in 1 VIAL (65219-403-01)", "package_ndc": "65219-403-03", "marketing_start_date": "20221227"}], "brand_name": "Zinc Sulfate", "product_id": "65219-403_af258d83-398d-4601-ab09-14c9fe383cc2", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "65219-403", "generic_name": "Zinc Sulfate", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zinc Sulfate", "active_ingredients": [{"name": "ZINC SULFATE", "strength": "3 mg/mL"}], "application_number": "ANDA216145", "marketing_category": "ANDA", "marketing_start_date": "20221227", "listing_expiration_date": "20261231"}