allopurinol

Generic: allopurinol

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

Drug Facts

Product Profile

Brand Name allopurinol
Generic Name allopurinol
Labeler gland pharma limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

allopurinol sodium 500 mg/25mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-380
Product ID 68083-380_6a0eaf66-34ca-4ba5-a2c6-a3c369ddf30c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212363
Listing Expiration 2026-12-31
Marketing Start 2022-01-26

Pharmacologic Class

Classes
xanthine oxidase inhibitor [epc] xanthine oxidase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083380
Hyphenated Format 68083-380

Supplemental Identifiers

RxCUI
252931
UPC
0368083380014
UNII
428673RC2Z

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 allopurinol (source: ndc)
Generic Name allopurinol (source: ndc)
Application Number ANDA212363 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/25mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (68083-380-01) / 25 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

68083-380-01 1 VIAL, GLASS in 1 CARTON (68083-380-01) / 25 mL in 1 VIAL, GLASS

Ingredients (1)

allopurinol sodium (500 mg/25mL)

Linked Drug Pages (1)

Allopurinol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "6a0eaf66-34ca-4ba5-a2c6-a3c369ddf30c", "openfda": {"upc": ["0368083380014"], "unii": ["428673RC2Z"], "rxcui": ["252931"], "spl_set_id": ["4839e842-511e-4c72-9153-2b7e4e1954e2"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (68083-380-01)  / 25 mL in 1 VIAL, GLASS", "package_ndc": "68083-380-01", "marketing_start_date": "20220126"}], "brand_name": "Allopurinol", "product_id": "68083-380_6a0eaf66-34ca-4ba5-a2c6-a3c369ddf30c", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Xanthine Oxidase Inhibitor [EPC]", "Xanthine Oxidase Inhibitors [MoA]"], "product_ndc": "68083-380", "generic_name": "Allopurinol", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Allopurinol", "active_ingredients": [{"name": "ALLOPURINOL SODIUM", "strength": "500 mg/25mL"}], "application_number": "ANDA212363", "marketing_category": "ANDA", "marketing_start_date": "20220126", "listing_expiration_date": "20261231"}