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 100 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-678
Product ID 71610-678_8fc2ce8f-5707-4329-adc7-b1776451e7ea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203154
Listing Expiration 2026-12-31
Marketing Start 2015-04-29

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 71610678
Hyphenated Format 71610-678

Supplemental Identifiers

RxCUI
197319
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 ANDA203154 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71610-678-30)
  • 90 TABLET in 1 BOTTLE (71610-678-60)
  • 180 TABLET in 1 BOTTLE (71610-678-80)
source: ndc

Packages (3)

71610-678-30 30 TABLET in 1 BOTTLE (71610-678-30) 71610-678-60 90 TABLET in 1 BOTTLE (71610-678-60) 71610-678-80 180 TABLET in 1 BOTTLE (71610-678-80)

Ingredients (1)

allopurinol (100 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": "8fc2ce8f-5707-4329-adc7-b1776451e7ea", "openfda": {"nui": ["N0000175698", "N0000000206"], "unii": ["63CZ7GJN5I"], "rxcui": ["197319"], "spl_set_id": ["0155151c-6e84-4f9b-9233-60ffa7483293"], "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": "30 TABLET in 1 BOTTLE (71610-678-30)", "package_ndc": "71610-678-30", "marketing_start_date": "20221123"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-678-60)", "package_ndc": "71610-678-60", "marketing_start_date": "20221123"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-678-80)", "package_ndc": "71610-678-80", "marketing_start_date": "20221123"}], "brand_name": "Allopurinol", "product_id": "71610-678_8fc2ce8f-5707-4329-adc7-b1776451e7ea", "dosage_form": "TABLET", "pharm_class": ["Xanthine Oxidase Inhibitor [EPC]", "Xanthine Oxidase Inhibitors [MoA]"], "product_ndc": "71610-678", "generic_name": "allopurinol", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Allopurinol", "active_ingredients": [{"name": "ALLOPURINOL", "strength": "100 mg/1"}], "application_number": "ANDA203154", "marketing_category": "ANDA", "marketing_start_date": "20150429", "listing_expiration_date": "20261231"}