FDA Orange Book
Generic for Bentyl Preservative Free
Bentyl Preservative Free 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 Preservative Free is dicyclomine. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Bentyl Preservative Free products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 10MG/ML | Discontinued | None | 7 | AP |
NDA 008370, held by ABBVIE INC. 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 |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 040465 | AP (A-rated, therapeutically equivalent) | June 30, 2003 | 10MG/ML |
| 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 |
| 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 |
Questions
Is there a generic for Bentyl Preservative Free?
Yes. The generic name for Bentyl Preservative Free is dicyclomine. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Bentyl Preservative Free?
The active ingredient in Bentyl Preservative Free 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.