allopurinol

Generic: allopurinol

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

Drug Facts

Product Profile

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

allopurinol 300 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-0181
Product ID 0378-0181_38f49ed2-9641-404b-8146-5555064b86e8
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 03780181
Hyphenated Format 0378-0181

Supplemental Identifiers

RxCUI
197319 197320
UNII
63CZ7GJN5I
NUI
N0000175698 N0000000206

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 ANDA018659 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0378-0181-01)
  • 500 TABLET in 1 BOTTLE (0378-0181-05)
source: ndc

Packages (2)

0378-0181-01 100 TABLET in 1 BOTTLE (0378-0181-01) 0378-0181-05 500 TABLET in 1 BOTTLE (0378-0181-05)

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": "38f49ed2-9641-404b-8146-5555064b86e8", "openfda": {"nui": ["N0000175698", "N0000000206"], "unii": ["63CZ7GJN5I"], "rxcui": ["197319", "197320"], "spl_set_id": ["bdbf5ad4-86f2-4e9c-a51a-fb0c7220c480"], "pharm_class_epc": ["Xanthine Oxidase Inhibitor [EPC]"], "pharm_class_moa": ["Xanthine Oxidase Inhibitors [MoA]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0378-0181-01)", "package_ndc": "0378-0181-01", "marketing_start_date": "19861024"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (0378-0181-05)", "package_ndc": "0378-0181-05", "marketing_start_date": "19861024"}], "brand_name": "Allopurinol", "product_id": "0378-0181_38f49ed2-9641-404b-8146-5555064b86e8", "dosage_form": "TABLET", "pharm_class": ["Xanthine Oxidase Inhibitor [EPC]", "Xanthine Oxidase Inhibitors [MoA]"], "product_ndc": "0378-0181", "generic_name": "allopurinol", "labeler_name": "Mylan Pharmaceuticals Inc.", "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"}