allopurinol

Generic: allopurinol

Labeler: par health usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name allopurinol
Generic Name allopurinol
Labeler par health usa, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

allopurinol 300 mg/1

Manufacturer
Par Health USA, LLC

Identifiers & Regulatory

Product NDC 0603-2116
Product ID 0603-2116_bb93f828-90b4-4844-9256-f4f964243818
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075798
Listing Expiration 2026-12-31
Marketing Start 2003-06-27

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 06032116
Hyphenated Format 0603-2116

Supplemental Identifiers

RxCUI
197319 197320
UPC
0306032115218 0306032116215
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 ANDA075798 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0603-2116-21)
  • 500 TABLET in 1 BOTTLE, PLASTIC (0603-2116-28)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (0603-2116-32)
source: ndc

Packages (3)

0603-2116-21 100 TABLET in 1 BOTTLE, PLASTIC (0603-2116-21) 0603-2116-28 500 TABLET in 1 BOTTLE, PLASTIC (0603-2116-28) 0603-2116-32 1000 TABLET in 1 BOTTLE, PLASTIC (0603-2116-32)

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": "bb93f828-90b4-4844-9256-f4f964243818", "openfda": {"nui": ["N0000175698", "N0000000206"], "upc": ["0306032115218", "0306032116215"], "unii": ["63CZ7GJN5I"], "rxcui": ["197319", "197320"], "spl_set_id": ["fbac3b4f-dc23-4359-ac3f-2b3fdde41af2"], "pharm_class_epc": ["Xanthine Oxidase Inhibitor [EPC]"], "pharm_class_moa": ["Xanthine Oxidase Inhibitors [MoA]"], "manufacturer_name": ["Par Health USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0603-2116-21)", "package_ndc": "0603-2116-21", "marketing_start_date": "20030627"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (0603-2116-28)", "package_ndc": "0603-2116-28", "marketing_start_date": "20030627"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (0603-2116-32)", "package_ndc": "0603-2116-32", "marketing_start_date": "20030627"}], "brand_name": "Allopurinol", "product_id": "0603-2116_bb93f828-90b4-4844-9256-f4f964243818", "dosage_form": "TABLET", "pharm_class": ["Xanthine Oxidase Inhibitor [EPC]", "Xanthine Oxidase Inhibitors [MoA]"], "product_ndc": "0603-2116", "generic_name": "allopurinol", "labeler_name": "Par Health USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Allopurinol", "active_ingredients": [{"name": "ALLOPURINOL", "strength": "300 mg/1"}], "application_number": "ANDA075798", "marketing_category": "ANDA", "marketing_start_date": "20030627", "listing_expiration_date": "20261231"}