FDA Orange Book

Generic for Inapsine

Inapsine contains droperidol. 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 Inapsine is droperidol. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

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Inapsine products in the Orange Book

Inapsine products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
injectable, injection2.5MG/MLDiscontinuedNone2AP

NDA 016796, held by RISING PHARMA HOLDINGS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic droperidol

Approved generic versions of Inapsine
CompanyANDATE codeApprovedStrengths
AMERICAN REGENT INC072123AP (A-rated, therapeutically equivalent)October 24, 19882.5MG/ML
HIKMA PHARMACEUTICALS USA INC208197AP (A-rated, therapeutically equivalent)December 14, 20172.5MG/ML

Questions

Is there a generic for Inapsine?

Yes. The generic name for Inapsine is droperidol. 2 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 Inapsine?

The active ingredient in Inapsine is droperidol, 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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