FDA Orange Book

Generic for Aggrenox

Aggrenox contains aspirin and dipyridamole. 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 Aggrenox is aspirin and dipyridamole. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Aggrenox products in the Orange Book

Aggrenox products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, extended release, oral25MG;200MGDiscontinuedNone8AB

NDA 020884, held by BOEHRINGER INGELHEIM PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic aspirin and dipyridamole

Approved generic versions of Aggrenox
CompanyANDATE codeApprovedStrengths
BARR LABORATORIES INC078804AB (A-rated, therapeutically equivalent)August 14, 200925MG;200MG
AMNEAL PHARMACEUTICALS OF NEW YORK LLC206392AB (A-rated, therapeutically equivalent)March 8, 201625MG;200MG
PH HEALTH LTD207944AB (A-rated, therapeutically equivalent)January 18, 201725MG;200MG
SANDOZ INC206739AB (A-rated, therapeutically equivalent)January 18, 201725MG;200MG
ZYDUS PHARMACEUTICALS USA INC206753AB (A-rated, therapeutically equivalent)August 29, 201725MG;200MG
DR REDDYS LABORATORIES LTD209048AB (A-rated, therapeutically equivalent)October 10, 201825MG;200MG
GLENMARK SPECIALTY SA210318AB (A-rated, therapeutically equivalent)May 24, 201925MG;200MG
MICRO LABS LTD209929AB (A-rated, therapeutically equivalent)August 11, 202125MG;200MG

Questions

Is there a generic for Aggrenox?

Yes. The generic name for Aggrenox is aspirin and dipyridamole. 8 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 Aggrenox?

The active ingredient in Aggrenox is aspirin and dipyridamole, 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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