FDA Orange Book

Generic for Biltricide

Biltricide contains praziquantel. 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 Biltricide is praziquantel. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.

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Biltricide products in the Orange Book

Biltricide products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, oral600MGDiscontinuedNone1None

NDA 018714, held by BAYER HEALTHCARE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic praziquantel

Approved generic versions of Biltricide
CompanyANDATE codeApprovedStrengths
PH HEALTH LTD208820None (No TE code listed)November 27, 2017600MG

Biltricide NDC codes

Questions

Is there a generic for Biltricide?

Yes. The generic name for Biltricide is praziquantel. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.

What is the generic name for Biltricide?

The active ingredient in Biltricide is praziquantel, 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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