Is Bentyl still available?

Bentyl (NDA 007409) is listed as Discontinued in the FDA Orange Book — it is no longer marketed. A discontinued status is not, by itself, a determination that the drug was withdrawn for safety or effectiveness.

Does Bentyl have a generic?

Yes. The Orange Book lists 42 approved generic (ANDA) applications sharing Bentyl's active ingredient (Dicyclomine Hydrochloride). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What is Bentyl's FDA application number?

Bentyl is approved under NDA 007409, held by Allergan.

Orange Book product · Brand (NDA)

Bentyl

Dicyclomine Hydrochloride

Brand (NDA)NDA 007409DiscontinuedRLD Allergan

Approved

Oct 15, 1984

Application

Brand (NDA)

TE code

Not listed

Listed patents

Bentyl (Dicyclomine Hydrochloride) is Allergan's brand-name drug, approved by the FDA under NDA 007409 in 1984. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 42 approved generics share this drug's active ingredient.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Oct 15, 1984
42 yr 4 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

DICYCLOMINE HYDROCHLORIDE

Strength

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 007409

Product number

003

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

Same application

Other strengths in NDA 007409

20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Dicyclomine Hydrochloride family

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Bentyl — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Dicyclomine Hydrochloride active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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