FDA Orange Book

Generic for Inderal LA

Inderal LA contains propranolol. 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 Inderal LA is propranolol. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Inderal LA products in the Orange Book

Inderal LA products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, extended release, oral120MGMarketed (Rx)AB8AB
capsule, extended release, oral160MGMarketed (Rx)AB8AB
capsule, extended release, oral60MGMarketed (Rx)AB8AB
capsule, extended release, oral80MGMarketed (Rx)AB8AB

NDA 018553, held by ANI PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic propranolol

Approved generic versions of Inderal LA
CompanyANDATE codeApprovedStrengths
ANDA REPOSITORY LLC078065AB (A-rated, therapeutically equivalent)January 26, 2007120MG, 160MG, 60MG, 80MG
ACTAVIS ELIZABETH LLC078494AB (A-rated, therapeutically equivalent)August 10, 2007120MG, 160MG, 60MG, 80MG
ZYDUS PHARMACEUTICALS USA INC090321AB (A-rated, therapeutically equivalent)March 25, 2011120MG, 160MG, 60MG, 80MG
ADARE PHARMACEUTICALS INC078703AB (A-rated, therapeutically equivalent)July 15, 2011120MG, 160MG, 60MG, 80MG
AMTA LABS LTD212026AB (A-rated, therapeutically equivalent)January 6, 2020120MG, 160MG, 60MG, 80MG
IPCA LABORATORIES LTD203103AB (A-rated, therapeutically equivalent)May 1, 2026120MG, 160MG, 60MG, 80MG
MICRO LABS LTD217238AB (A-rated, therapeutically equivalent)June 24, 2026120MG, 160MG, 60MG, 80MG
CREEKWOOD PHARMACEUTICALS LLC219460AB (A-rated, therapeutically equivalent)August 14, 2026120MG, 160MG, 60MG, 80MG

Inderal LA NDC codes

Questions

Is there a generic for Inderal LA?

Yes. The generic name for Inderal LA is propranolol. 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 Inderal LA?

The active ingredient in Inderal LA is propranolol, 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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