allopurinol

Generic: allopurinol

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA 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 43353-186
Product ID 43353-186_8b90efb6-87d0-428c-b0ef-13237a009714
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA018659
Listing Expiration 2026-12-31
Marketing Start 1986-10-24

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 43353186
Hyphenated Format 43353-186

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 ANDA018659 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (43353-186-60)
source: ndc

Packages (1)

43353-186-60 90 TABLET in 1 BOTTLE (43353-186-60)

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": "8b90efb6-87d0-428c-b0ef-13237a009714", "openfda": {"nui": ["N0000175698", "N0000000206"], "unii": ["63CZ7GJN5I"], "rxcui": ["197320"], "spl_set_id": ["aea483a7-4ce7-4fe5-936c-fd876b4fa3a8"], "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": "90 TABLET in 1 BOTTLE (43353-186-60)", "package_ndc": "43353-186-60", "marketing_start_date": "20160617"}], "brand_name": "Allopurinol", "product_id": "43353-186_8b90efb6-87d0-428c-b0ef-13237a009714", "dosage_form": "TABLET", "pharm_class": ["Xanthine Oxidase Inhibitor [EPC]", "Xanthine Oxidase Inhibitors [MoA]"], "product_ndc": "43353-186", "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": "ANDA018659", "marketing_category": "ANDA", "marketing_start_date": "19861024", "listing_expiration_date": "20261231"}