FDA Orange Book

Generic for Dynacirc

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

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Dynacirc products in the Orange Book

Dynacirc products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, oral2.5MGDiscontinuedNone2AB
capsule, oral5MGDiscontinuedNone2AB

NDA 019546, held by SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic isradipine

Approved generic versions of Dynacirc
CompanyANDATE codeApprovedStrengths
WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC077317AB (A-rated, therapeutically equivalent)January 5, 20062.5MG, 5MG
ELITE LABORATORIES INC077169AB (A-rated, therapeutically equivalent)April 24, 20062.5MG, 5MG

Questions

Is there a generic for Dynacirc?

Yes. The generic name for Dynacirc is isradipine. 2 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 Dynacirc?

The active ingredient in Dynacirc is isradipine, 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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