FDA Orange Book

Is there a generic for Cardura XL?

Cardura XL contains doxazosin. 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

No. The Orange Book lists no active FDA-approved generic (ANDA) for Cardura XL (doxazosin).

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Cardura XL products in the Orange Book

Cardura XL products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, extended release, oralEQ 4MG BASEMarketed (Rx)None0None
tablet, extended release, oralEQ 8MG BASEMarketed (Rx)None0None

NDA 021269, held by VIATRIS SPECIALTY LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Cardura XL NDC codes

Questions

Is there a generic for Cardura XL?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Cardura XL (doxazosin).

What is the generic name for Cardura XL?

The active ingredient in Cardura XL is doxazosin, 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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