FDA Orange Book
Generic for Ditropan
Ditropan 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 is oxybutynin chloride. 14 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
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Ditropan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| syrup, oral | 5MG/5ML | Discontinued | None | 2 | AA |
| tablet, oral | 5MG | Discontinued | None | 12 | AB |
NDA 018211, 017577, held by ORTHO MCNEIL 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 |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 071655 | AB (A-rated, therapeutically equivalent) | November 14, 1988 | 5MG |
| LANNETT CO INC | 074520 | AA (A-rated, therapeutically equivalent) | March 29, 1996 | 5MG/5ML |
| AIPING PHARMACEUTICAL INC | 074625 | AB (A-rated, therapeutically equivalent) | July 31, 1996 | 5MG |
| STRIDES PHARMA INTERNATIONAL AG | 075079 | AB (A-rated, therapeutically equivalent) | October 31, 1997 | 5MG |
| CHARTWELL RX SCIENCES LLC | 075039 | AA (A-rated, therapeutically equivalent) | January 29, 1999 | 5MG/5ML |
| NOVITIUM PHARMA LLC | 209823 | AB (A-rated, therapeutically equivalent) | October 23, 2017 | 5MG |
| RISING PHARMA HOLDINGS INC | 209025 | AB (A-rated, therapeutically equivalent) | December 21, 2017 | 5MG |
| ABHAI LLC | 209335 | AB (A-rated, therapeutically equivalent) | December 22, 2017 | 5MG |
| TP ANDA HOLDINGS LLC | 210125 | AB (A-rated, therapeutically equivalent) | September 6, 2018 | 5MG |
| HERITAGE PHARMA LABS INC DBA AVET PHARMACEUTICALS LABS INC | 211682 | AB (A-rated, therapeutically equivalent) | May 10, 2019 | 5MG |
| NOVAST LABORATORIES LTD | 210611 | AB (A-rated, therapeutically equivalent) | October 30, 2019 | 5MG |
| LEADING PHARMA LLC | 212798 | AB (A-rated, therapeutically equivalent) | April 6, 2020 | 5MG |
| STRIDES PHARMA GLOBAL PTE LTD | 208165 | AB (A-rated, therapeutically equivalent) | December 17, 2020 | 5MG |
| REGCON HOLDINGS LLC | 213550 | AB (A-rated, therapeutically equivalent) | July 14, 2022 | 5MG |
Questions
Is there a generic for Ditropan?
Yes. The generic name for Ditropan is oxybutynin chloride. 14 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
What is the generic name for Ditropan?
The active ingredient in Ditropan 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.