zinc sulfate

Generic: zinc sulfate

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zinc sulfate
Generic Name zinc sulfate
Labeler somerset therapeutics, llc
Dosage Form SOLUTION
Routes
INTRAVENOUS
Active Ingredients

zinc sulfate 5 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-691
Product ID 70069-691_e1880316-9556-4529-8ba1-8669113a993e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216135
Listing Expiration 2026-12-31
Marketing Start 2024-07-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069691
Hyphenated Format 70069-691

Supplemental Identifiers

RxCUI
2201521 2201524
UPC
0370069692257 0370069691014 0370069692011
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 ANDA216135 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (70069-691-25) / 5 mL in 1 VIAL (70069-691-01)
source: ndc

Packages (1)

70069-691-25 25 VIAL in 1 CARTON (70069-691-25) / 5 mL in 1 VIAL (70069-691-01)

Ingredients (1)

zinc sulfate (5 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": "e1880316-9556-4529-8ba1-8669113a993e", "openfda": {"upc": ["0370069692257", "0370069691014", "0370069692011"], "unii": ["89DS0H96TB"], "rxcui": ["2201521", "2201524"], "spl_set_id": ["c9d45d0e-a165-4112-81f9-c0e455572ecf"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (70069-691-25)  / 5 mL in 1 VIAL (70069-691-01)", "package_ndc": "70069-691-25", "marketing_start_date": "20240718"}], "brand_name": "Zinc sulfate", "product_id": "70069-691_e1880316-9556-4529-8ba1-8669113a993e", "dosage_form": "SOLUTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "70069-691", "generic_name": "Zinc sulfate", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zinc sulfate", "active_ingredients": [{"name": "ZINC SULFATE", "strength": "5 mg/mL"}], "application_number": "ANDA216135", "marketing_category": "ANDA", "marketing_start_date": "20240718", "listing_expiration_date": "20261231"}