FDA Orange Book · active-ingredient family
Allopurinol
Allopurinol: 6 brands, 27 generics; first approved Sep 28, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 27 ANDA applications approved.
Brands (NDA)
6
Generics (ANDA)
27
Listed patents
0
Presentations
56
Brand (NDA) products
Originator applications
- ZYLOPRIMRLDCASPER PHARMA LLCNDA 016084—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - ALLOPURINOLWATSON LABSNDA 01824119842 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — - ALLOPURINOLWATSON LABSNDA 01878519842 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — - ALLOPURINOLWATSON LABSNDA 0188321984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB - ALLOPURINOLWATSON LABSNDA 0188771984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Rx AB - ABBOTTNDA 018297—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued —
Generic (ANDA) products (27)
Abbreviated applications
- ALLOPURINOLAUROBINDO PHARMA LTDANDA 21509120252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - ALLOPURINOLLUPINANDA 21180720232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — - ALLOPURINOLHETERO LABS LTD VANDA 21774820232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - ALLOPURINOLHARMAN FINOCHEMANDA 21444320223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - ALLOPURINOLUNICHEMANDA 21182020192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - ALLOPURINOLZYDUS PHARMSANDA 21011720173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - ALLOPURINOLREGCON HOLDINGSANDA 20446720163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - ALLOPURINOLACCORD HLTHCAREANDA 20315420132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - ALLOPURINOLIPCA LABS LTDANDA 09063720112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — - ALLOPURINOLNORTHSTAR HLTHCAREANDA 07825320072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — - ALLOPURINOLSUN PHARM INDS INCANDA 07839020072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — - ALLOPURINOLCHARTWELLANDA 07735320052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - ALLOPURINOLPH HEALTHANDA 07579820032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - ALLOPURINOLSUPERPHARMANDA 0709501988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - ALLOPURINOLSUPERPHARMANDA 0709511988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Discontinued — - DR REDDYSANDA 0715861987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB - DR REDDYSANDA 0715871987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Rx AB - ALLOPURINOLSUN PHARM INDUSTRIESANDA 07145019872 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - ALLOPURINOLMYLANANDA 01865919862 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - ALLOPURINOLPUREPAC PHARMANDA 0705791986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - ALLOPURINOLPUREPAC PHARMANDA 0705801986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Discontinued — - ALLOPURINOLAIPING PHARM INCANDA 0702681985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - ALLOPURINOLSANDOZANDA 0702691985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Discontinued — - ALLOPURINOLMUTUAL PHARMANDA 0704661985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - ALLOPURINOLMUTUAL PHARMANDA 0704671985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Discontinued — - ALLOPURINOLPURACAP PHARMANDA 0701501985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - ALLOPURINOLPURACAP PHARMANDA 0701471985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
42 yr 6 mo ago
Most recent approval
1 yr 3 mo ago
Approvals span 1984–2025 across 33 FDA applications.
Brand (NDA) 618%
Generic (ANDA) 2782%
Allopurinol: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
