allopurinol

Generic: allopurinol

Labeler: harman finochem limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name allopurinol
Generic Name allopurinol
Labeler harman finochem limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

allopurinol 300 mg/1

Manufacturer
Harman Finochem Limited

Identifiers & Regulatory

Product NDC 82638-113
Product ID 82638-113_2b4201b6-c125-05d2-e063-6294a90a58c1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214443
Listing Expiration 2026-12-31
Marketing Start 2023-10-06

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 82638113
Hyphenated Format 82638-113

Supplemental Identifiers

RxCUI
197319 197320
UPC
0382638112042 0382638113049 0382638112035 0382638113032 0382638113025 0382638112011 0382638112028
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 ANDA214443 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (82638-113-02)
  • 500 TABLET in 1 BOTTLE (82638-113-03)
  • 1000 TABLET in 1 BOTTLE (82638-113-04)
source: ndc

Packages (3)

82638-113-02 100 TABLET in 1 BOTTLE (82638-113-02) 82638-113-03 500 TABLET in 1 BOTTLE (82638-113-03) 82638-113-04 1000 TABLET in 1 BOTTLE (82638-113-04)

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": "2b4201b6-c125-05d2-e063-6294a90a58c1", "openfda": {"nui": ["N0000175698", "N0000000206"], "upc": ["0382638112042", "0382638113049", "0382638112035", "0382638113032", "0382638113025", "0382638112011", "0382638112028"], "unii": ["63CZ7GJN5I"], "rxcui": ["197319", "197320"], "spl_set_id": ["0780dc78-d287-d5db-e063-6294a90aa1dd"], "pharm_class_epc": ["Xanthine Oxidase Inhibitor [EPC]"], "pharm_class_moa": ["Xanthine Oxidase Inhibitors [MoA]"], "manufacturer_name": ["Harman Finochem Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (82638-113-02)", "package_ndc": "82638-113-02", "marketing_start_date": "20231006"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (82638-113-03)", "package_ndc": "82638-113-03", "marketing_start_date": "20231006"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (82638-113-04)", "package_ndc": "82638-113-04", "marketing_start_date": "20231006"}], "brand_name": "Allopurinol", "product_id": "82638-113_2b4201b6-c125-05d2-e063-6294a90a58c1", "dosage_form": "TABLET", "pharm_class": ["Xanthine Oxidase Inhibitor [EPC]", "Xanthine Oxidase Inhibitors [MoA]"], "product_ndc": "82638-113", "generic_name": "Allopurinol", "labeler_name": "Harman Finochem Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Allopurinol", "active_ingredients": [{"name": "ALLOPURINOL", "strength": "300 mg/1"}], "application_number": "ANDA214443", "marketing_category": "ANDA", "marketing_start_date": "20231006", "listing_expiration_date": "20261231"}