allopurinol

Generic: allopurinol

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name allopurinol
Generic Name allopurinol
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

allopurinol 300 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 67544-313
Product ID 67544-313_c5d95534-5585-40ff-9d6c-8b4a62c1b101
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018877
Listing Expiration 2026-12-31
Marketing Start 2009-04-06

Pharmacologic Class

Established (EPC)
xanthine oxidase inhibitor [epc]
Mechanism of Action
xanthine oxidase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67544313
Hyphenated Format 67544-313

Supplemental Identifiers

RxCUI
197320
UNII
63CZ7GJN5I
NUI
N0000175698 N0000000206

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 NDA018877 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 45 TABLET in 1 BOTTLE, PLASTIC (67544-313-45)
  • 90 TABLET in 1 BOTTLE, PLASTIC (67544-313-60)
source: ndc

Packages (2)

67544-313-45 45 TABLET in 1 BOTTLE, PLASTIC (67544-313-45) 67544-313-60 90 TABLET in 1 BOTTLE, PLASTIC (67544-313-60)

Ingredients (1)

allopurinol (300 mg/1)

Linked Drug Pages (1)

Allopurinol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c5d95534-5585-40ff-9d6c-8b4a62c1b101", "openfda": {"nui": ["N0000175698", "N0000000206"], "unii": ["63CZ7GJN5I"], "rxcui": ["197320"], "spl_set_id": ["9b0e3f11-c02a-443d-806f-134c907ea371"], "pharm_class_epc": ["Xanthine Oxidase Inhibitor [EPC]"], "pharm_class_moa": ["Xanthine Oxidase Inhibitors [MoA]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "45 TABLET in 1 BOTTLE, PLASTIC (67544-313-45)", "package_ndc": "67544-313-45", "marketing_start_date": "20221221"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (67544-313-60)", "package_ndc": "67544-313-60", "marketing_start_date": "20221221"}], "brand_name": "Allopurinol", "product_id": "67544-313_c5d95534-5585-40ff-9d6c-8b4a62c1b101", "dosage_form": "TABLET", "pharm_class": ["Xanthine Oxidase Inhibitor [EPC]", "Xanthine Oxidase Inhibitors [MoA]"], "product_ndc": "67544-313", "generic_name": "Allopurinol", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Allopurinol", "active_ingredients": [{"name": "ALLOPURINOL", "strength": "300 mg/1"}], "application_number": "NDA018877", "marketing_category": "NDA", "marketing_start_date": "20090406", "listing_expiration_date": "20261231"}