allopurinol

Generic: allopurinol

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name allopurinol
Generic Name allopurinol
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

allopurinol 100 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8458
Product ID 68788-8458_92bc61cd-b263-4e1a-8387-f82b295df68b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211820
Listing Expiration 2027-12-31
Marketing Start 2023-06-14

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 687888458
Hyphenated Format 68788-8458

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 ANDA211820 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (68788-8458-1)
  • 30 TABLET in 1 BOTTLE, PLASTIC (68788-8458-3)
  • 60 TABLET in 1 BOTTLE, PLASTIC (68788-8458-6)
  • 90 TABLET in 1 BOTTLE, PLASTIC (68788-8458-9)
source: ndc

Packages (4)

68788-8458-1 100 TABLET in 1 BOTTLE, PLASTIC (68788-8458-1) 68788-8458-3 30 TABLET in 1 BOTTLE, PLASTIC (68788-8458-3) 68788-8458-6 60 TABLET in 1 BOTTLE, PLASTIC (68788-8458-6) 68788-8458-9 90 TABLET in 1 BOTTLE, PLASTIC (68788-8458-9)

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": "92bc61cd-b263-4e1a-8387-f82b295df68b", "openfda": {"nui": ["N0000175698", "N0000000206"], "unii": ["63CZ7GJN5I"], "rxcui": ["197319"], "spl_set_id": ["e11e94b9-d897-48ce-9a80-aa6b8b5fde02"], "pharm_class_epc": ["Xanthine Oxidase Inhibitor [EPC]"], "pharm_class_moa": ["Xanthine Oxidase Inhibitors [MoA]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (68788-8458-1)", "package_ndc": "68788-8458-1", "marketing_start_date": "20230614"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (68788-8458-3)", "package_ndc": "68788-8458-3", "marketing_start_date": "20230614"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (68788-8458-6)", "package_ndc": "68788-8458-6", "marketing_start_date": "20230614"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (68788-8458-9)", "package_ndc": "68788-8458-9", "marketing_start_date": "20230614"}], "brand_name": "Allopurinol", "product_id": "68788-8458_92bc61cd-b263-4e1a-8387-f82b295df68b", "dosage_form": "TABLET", "pharm_class": ["Xanthine Oxidase Inhibitor [EPC]", "Xanthine Oxidase Inhibitors [MoA]"], "product_ndc": "68788-8458", "generic_name": "Allopurinol", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Allopurinol", "active_ingredients": [{"name": "ALLOPURINOL", "strength": "100 mg/1"}], "application_number": "ANDA211820", "marketing_category": "ANDA", "marketing_start_date": "20230614", "listing_expiration_date": "20271231"}