FDA Orange Book
Generic for Zyloprim
Zyloprim contains allopurinol. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Zyloprim is allopurinol. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Zyloprim products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | 200MG | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | 300MG | Marketed (Rx) | AB | 12 | AB |
NDA 016084, held by CASPER PHARMA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic allopurinol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 018659 | AB (A-rated, therapeutically equivalent) | October 24, 1986 | 100MG, 300MG |
| SUN PHARMACEUTICAL INDUSTRIES INC | 071450 | AB (A-rated, therapeutically equivalent) | January 9, 1987 | 100MG, 300MG |
| DR REDDYS LABORATORIES INC | 071587 | AB (A-rated, therapeutically equivalent) | April 2, 1987 | 100MG, 300MG |
| PH HEALTH LTD | 075798 | AB (A-rated, therapeutically equivalent) | June 27, 2003 | 100MG, 300MG |
| CHARTWELL LIFE MOLECULES LLC | 077353 | AB (A-rated, therapeutically equivalent) | September 8, 2005 | 100MG, 300MG |
| ACCORD HEALTHCARE INC | 203154 | AB (A-rated, therapeutically equivalent) | May 6, 2013 | 100MG, 300MG |
| REGCON HOLDINGS LLC | 204467 | AB (A-rated, therapeutically equivalent) | July 28, 2016 | 100MG, 200MG, 300MG |
| ZYDUS PHARMACEUTICALS USA INC | 210117 | AB (A-rated, therapeutically equivalent) | October 12, 2017 | 100MG, 200MG, 300MG |
| UNICHEM LABORATORIES LTD | 211820 | AB (A-rated, therapeutically equivalent) | March 12, 2019 | 100MG, 300MG |
| HARMAN FINOCHEM LTD | 214443 | AB (A-rated, therapeutically equivalent) | March 7, 2022 | 100MG, 200MG, 300MG |
| HETERO LABS LTD UNIT V | 217748 | AB (A-rated, therapeutically equivalent) | August 3, 2023 | 100MG, 300MG |
| AUROBINDO PHARMA LTD | 215091 | AB (A-rated, therapeutically equivalent) | April 14, 2025 | 100MG, 300MG |
Zyloprim NDC codes
Questions
Is there a generic for Zyloprim?
Yes. The generic name for Zyloprim is allopurinol. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Zyloprim?
The active ingredient in Zyloprim is allopurinol, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.