FDA Orange Book
Generic for Bentyl
Bentyl contains dicyclomine. 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 Bentyl is dicyclomine. 18 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AP.
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Bentyl products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 10MG | Discontinued | None | 10 | AB |
| injectable, injection | 10MG/ML | Discontinued | None | 7 | AP |
| syrup, oral | 10MG/5ML | Discontinued | None | 3 | AA |
| tablet, oral | 20MG | Discontinued | None | 11 | AB |
NDA 007409, 008370, 007961, held by ALLERGAN SALES LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dicyclomine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| WATSON LABORATORIES INC | 085082 | AB (A-rated, therapeutically equivalent) | June 19, 1986 | 10MG |
| WATSON LABORATORIES INC | 085223 | AB (A-rated, therapeutically equivalent) | July 30, 1986 | 20MG |
| HIKMA PHARMACEUTICALS USA INC | 040161 | AB (A-rated, therapeutically equivalent) | October 1, 1996 | 20MG |
| HIKMA PHARMACEUTICALS USA INC | 040204 | AB (A-rated, therapeutically equivalent) | February 28, 1997 | 10MG |
| LANNETT CO INC | 040230 | AB (A-rated, therapeutically equivalent) | February 26, 1999 | 20MG |
| AUROBINDO PHARMA USA INC | 040319 | AB (A-rated, therapeutically equivalent) | September 7, 1999 | 10MG |
| AUROBINDO PHARMA USA INC | 040317 | AB (A-rated, therapeutically equivalent) | September 7, 1999 | 20MG |
| HIKMA PHARMACEUTICALS USA INC | 040465 | AP (A-rated, therapeutically equivalent) | June 30, 2003 | 10MG/ML |
| PH HEALTH LTD | 040169 | AA (A-rated, therapeutically equivalent) | March 24, 2005 | 10MG/5ML |
| AMERICAN REGENT INC | 208353 | AP (A-rated, therapeutically equivalent) | February 17, 2017 | 10MG/ML |
| FOSUN PHARMA USA INC | 210979 | AP (A-rated, therapeutically equivalent) | July 2, 2018 | 10MG/ML |
| SLATE RUN PHARMACEUTICALS LLC | 207076 | AP (A-rated, therapeutically equivalent) | November 2, 2018 | 10MG/ML |
| FRESENIUS KABI USA LLC | 210257 | AP (A-rated, therapeutically equivalent) | January 25, 2019 | 10MG/ML |
| HIKMA PHARMACEUTICALS USA INC | 212286 | AA (A-rated, therapeutically equivalent) | May 22, 2020 | 10MG/5ML |
| NOVITIUM PHARMA LLC | 214721 | AA (A-rated, therapeutically equivalent) | April 23, 2021 | 10MG/5ML |
| SOLGEN PHARMA LLC | 216760 | AB (A-rated, therapeutically equivalent) | November 28, 2022 | 20MG |
| RUBICON RESEARCH LTD | 216736 | AB (A-rated, therapeutically equivalent) | December 14, 2022 | 20MG |
| TWI PHARMACEUTICALS INC | 217054 | AB (A-rated, therapeutically equivalent) | December 27, 2022 | 10MG |
| SOLGEN PHARMA LLC | 216639 | AB (A-rated, therapeutically equivalent) | March 24, 2023 | 10MG |
| TWI PHARMACEUTICALS INC | 216782 | AB (A-rated, therapeutically equivalent) | June 1, 2023 | 20MG |
| BIONPHARMA INC | 217916 | AB (A-rated, therapeutically equivalent) | August 4, 2023 | 20MG |
| PRINSTON PHARMACEUTICAL INC | 217531 | AB (A-rated, therapeutically equivalent) | August 30, 2023 | 10MG |
| ANNORA PHARMA PRIVATE LTD | 217566 | AB (A-rated, therapeutically equivalent) | May 7, 2024 | 20MG |
| ANNORA PHARMA PRIVATE LTD | 218018 | AB (A-rated, therapeutically equivalent) | July 1, 2024 | 10MG |
| SOMERSET THERAPEUTICS LLC | 214332 | AP (A-rated, therapeutically equivalent) | November 1, 2024 | 10MG/ML |
| SOMERSET THERAPEUTICS LLC | 214333 | AP (A-rated, therapeutically equivalent) | November 1, 2024 | 10MG/ML |
| RISING PHARMA HOLDINGS INC | 218952 | AB (A-rated, therapeutically equivalent) | November 15, 2024 | 20MG |
| PRINSTON PHARMACEUTICAL INC | 218310 | AB (A-rated, therapeutically equivalent) | June 6, 2025 | 20MG |
| RISING PHARMA HOLDINGS INC | 219242 | AB (A-rated, therapeutically equivalent) | June 23, 2025 | 10MG |
| RUBICON RESEARCH LTD | 216515 | AB (A-rated, therapeutically equivalent) | July 17, 2026 | 10MG |
| LANNETT CO INC | 084285 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 10MG |
Questions
Is there a generic for Bentyl?
Yes. The generic name for Bentyl is dicyclomine. 18 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AP.
What is the generic name for Bentyl?
The active ingredient in Bentyl is dicyclomine, 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.