zinc sulfate

Generic: zinc sulfate

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zinc sulfate
Generic Name zinc sulfate
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

zinc sulfate 1 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-608
Product ID 68083-608_cfa59996-1de2-4313-a7ac-1766764513e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216249
Listing Expiration 2026-12-31
Marketing Start 2023-09-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083608
Hyphenated Format 68083-608

Supplemental Identifiers

RxCUI
2201521 2201524 2369390
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 ANDA216249 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (68083-608-25) / 10 mL in 1 VIAL
source: ndc

Packages (1)

68083-608-25 25 VIAL in 1 CARTON (68083-608-25) / 10 mL in 1 VIAL

Ingredients (1)

zinc sulfate (1 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": "cfa59996-1de2-4313-a7ac-1766764513e2", "openfda": {"unii": ["89DS0H96TB"], "rxcui": ["2201521", "2201524", "2369390"], "spl_set_id": ["8f354f0a-4e10-4e4e-b86c-49d97cbd631d"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (68083-608-25)  / 10 mL in 1 VIAL", "package_ndc": "68083-608-25", "marketing_start_date": "20230901"}], "brand_name": "Zinc Sulfate", "product_id": "68083-608_cfa59996-1de2-4313-a7ac-1766764513e2", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "68083-608", "generic_name": "Zinc Sulfate", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zinc Sulfate", "active_ingredients": [{"name": "ZINC SULFATE", "strength": "1 mg/mL"}], "application_number": "ANDA216249", "marketing_category": "ANDA", "marketing_start_date": "20230901", "listing_expiration_date": "20261231"}