FDA Orange Book
Generic for Plendil
Plendil contains felodipine. 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 Plendil is felodipine. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Plendil products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 10MG | Discontinued | None | 9 | AB |
| tablet, extended release, oral | 2.5MG | Discontinued | None | 9 | AB |
| tablet, extended release, oral | 5MG | Discontinued | None | 9 | AB |
NDA 019834, held by ASTRAZENECA PHARMACEUTICALS LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic felodipine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| GLENMARK PHARMACEUTICALS LTD | 090365 | AB (A-rated, therapeutically equivalent) | December 17, 2010 | 10MG, 2.5MG, 5MG |
| PH HEALTH LTD | 200815 | AB (A-rated, therapeutically equivalent) | October 28, 2011 | 10MG, 2.5MG, 5MG |
| TORRENT PHARMACEUTICALS LTD | 202170 | AB (A-rated, therapeutically equivalent) | November 28, 2011 | 10MG, 2.5MG, 5MG |
| AUROBINDO PHARMA LTD | 203417 | AB (A-rated, therapeutically equivalent) | January 17, 2013 | 10MG, 2.5MG, 5MG |
| HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC | 201964 | AB (A-rated, therapeutically equivalent) | November 8, 2013 | 10MG, 2.5MG, 5MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 091200 | AB (A-rated, therapeutically equivalent) | December 13, 2013 | 10MG, 2.5MG, 5MG |
| ORBION PHARMACEUTICALS PRIVATE LTD | 203032 | AB (A-rated, therapeutically equivalent) | May 21, 2015 | 10MG, 2.5MG, 5MG |
| PHARMOBEDIENT CONSULTING LLC | 210847 | AB (A-rated, therapeutically equivalent) | October 26, 2018 | 10MG, 2.5MG, 5MG |
| YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD | 204800 | AB (A-rated, therapeutically equivalent) | April 29, 2019 | 10MG, 2.5MG, 5MG |
Questions
Is there a generic for Plendil?
Yes. The generic name for Plendil is felodipine. 9 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 Plendil?
The active ingredient in Plendil is felodipine, 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.