FDA Orange Book

Generic for Citanest Plain

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

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Citanest Plain products in the Orange Book

Citanest Plain products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
injectable, injection4%DiscontinuedNone1None

NDA 014763, held by ASTRAZENECA LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic prilocaine

Approved generic versions of Citanest Plain
CompanyANDATE codeApprovedStrengths
SEPTODONT INC079235None (No TE code listed)September 29, 20104%

Questions

Is there a generic for Citanest Plain?

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

What is the generic name for Citanest Plain?

The active ingredient in Citanest Plain is prilocaine, 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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