FDA Orange Book
Generic for Ditropan XL
Ditropan XL contains oxybutynin chloride. 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 Ditropan XL is oxybutynin chloride. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Ditropan XL products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 10MG | Discontinued | None | 8 | AB |
| tablet, extended release, oral | 15MG | Discontinued | None | 8 | AB |
| tablet, extended release, oral | 5MG | Discontinued | None | 8 | AB |
NDA 020897, held by JANSSEN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic oxybutynin chloride
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| OSMOTICA PHARMACEUTICAL US LLC | 078503 | AB (A-rated, therapeutically equivalent) | February 4, 2009 | 10MG, 15MG, 5MG |
| AMNEAL PHARMACEUTICALS | 204010 | AB (A-rated, therapeutically equivalent) | November 23, 2015 | 10MG, 15MG, 5MG |
| ACCORD HEALTHCARE INC | 207138 | AB (A-rated, therapeutically equivalent) | February 29, 2016 | 10MG, 15MG, 5MG |
| UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD | 206121 | AB (A-rated, therapeutically equivalent) | May 27, 2016 | 10MG, 15MG, 5MG |
| ZYDUS PHARMACEUTICALS USA INC | 202332 | AB (A-rated, therapeutically equivalent) | June 26, 2017 | 10MG, 15MG, 5MG |
| AJANTA PHARMA LTD | 211655 | AB (A-rated, therapeutically equivalent) | February 28, 2019 | 10MG, 15MG, 5MG |
| BIONPHARMA INC | 210717 | AB (A-rated, therapeutically equivalent) | December 17, 2019 | 10MG, 15MG, 5MG |
| RUBICON RESEARCH LTD | 214415 | AB (A-rated, therapeutically equivalent) | October 27, 2020 | 10MG, 15MG, 5MG |
Questions
Is there a generic for Ditropan XL?
Yes. The generic name for Ditropan XL is oxybutynin chloride. 8 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 Ditropan XL?
The active ingredient in Ditropan XL is oxybutynin chloride, 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.