FDA Orange Book
Generic for InnoPran XL
InnoPran XL 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 InnoPran XL 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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InnoPran XL products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 120MG | Marketed (Rx) | BX | 8 | AB |
| capsule, extended release, oral | 80MG | Marketed (Rx) | BX | 8 | AB |
NDA 021438, 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
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ANDA REPOSITORY LLC | 078065 | AB (A-rated, therapeutically equivalent) | January 26, 2007 | 120MG, 80MG |
| ACTAVIS ELIZABETH LLC | 078494 | AB (A-rated, therapeutically equivalent) | August 10, 2007 | 120MG, 80MG |
| ZYDUS PHARMACEUTICALS USA INC | 090321 | AB (A-rated, therapeutically equivalent) | March 25, 2011 | 120MG, 80MG |
| ADARE PHARMACEUTICALS INC | 078703 | AB (A-rated, therapeutically equivalent) | July 15, 2011 | 120MG, 80MG |
| AMTA LABS LTD | 212026 | AB (A-rated, therapeutically equivalent) | January 6, 2020 | 120MG, 80MG |
| IPCA LABORATORIES LTD | 203103 | AB (A-rated, therapeutically equivalent) | May 1, 2026 | 120MG, 80MG |
| MICRO LABS LTD | 217238 | AB (A-rated, therapeutically equivalent) | June 24, 2026 | 120MG, 80MG |
| CREEKWOOD PHARMACEUTICALS LLC | 219460 | AB (A-rated, therapeutically equivalent) | August 14, 2026 | 120MG, 80MG |
InnoPran XL NDC codes
Questions
Is there a generic for InnoPran XL?
Yes. The generic name for InnoPran XL 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 InnoPran XL?
The active ingredient in InnoPran XL 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.
More on InnoPran XL and Propranolol
- What is Propranolol used for?FDA label uses
- Is Propranolol a controlled substance?Federal schedule
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- Generic for HemangeolFDA Orange Book
- Generic for InderalFDA Orange Book
- Beta Blockers listFDA drug class
- NDC 62559-590InnoPran XL NDC record
- NDC 62559-591InnoPran XL NDC record