FDA Orange Book

Generic for Nimotop

Nimotop contains nimodipine. 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 Nimotop is nimodipine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Nimotop products in the Orange Book

Nimotop products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, oral30MGDiscontinuedNone3AB

NDA 018869, held by BAYER PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic nimodipine

Approved generic versions of Nimotop
CompanyANDATE codeApprovedStrengths
HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC077811AB (A-rated, therapeutically equivalent)May 2, 200730MG
BIONPHARMA INC076740AB (A-rated, therapeutically equivalent)January 17, 200830MG
THEPHARMANETWORK LLC090103AB (A-rated, therapeutically equivalent)April 7, 201430MG

Questions

Is there a generic for Nimotop?

Yes. The generic name for Nimotop is nimodipine. 3 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 Nimotop?

The active ingredient in Nimotop is nimodipine, 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.

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