FDA Orange Book
Generic for Isoptin
Isoptin contains verapamil. 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 Isoptin is verapamil. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
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Isoptin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 2.5MG/ML | Discontinued | None | 8 | AP |
| tablet, oral | 120MG | Discontinued | None | 2 | AB |
| tablet, oral | 40MG | Discontinued | None | 2 | AB |
| tablet, oral | 80MG | Discontinued | None | 2 | AB |
NDA 018485, 018593, held by MT ADAMS TECHNOLOGIES LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic verapamil
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| WATSON LABORATORIES INC | 070994 | AB (A-rated, therapeutically equivalent) | October 1, 1986 | 120MG |
| WATSON LABORATORIES INC | 070995 | AB (A-rated, therapeutically equivalent) | October 1, 1986 | 80MG |
| HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC | 071881 | AB (A-rated, therapeutically equivalent) | April 5, 1988 | 120MG, 40MG, 80MG |
| WATSON LABORATORIES INC | 072924 | AB (A-rated, therapeutically equivalent) | June 29, 1993 | 40MG |
| EUGIA PHARMA SPECIALITIES LTD | 212965 | AP (A-rated, therapeutically equivalent) | July 6, 2020 | 2.5MG/ML |
| GLAND PHARMA LTD | 214361 | AP (A-rated, therapeutically equivalent) | October 15, 2020 | 2.5MG/ML |
| ZYDUS PHARMACEUTICALS USA INC | 214215 | AP (A-rated, therapeutically equivalent) | October 15, 2020 | 2.5MG/ML |
| HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC | 215829 | AP (A-rated, therapeutically equivalent) | March 17, 2022 | 2.5MG/ML |
| MANKIND PHARMA LTD | 214653 | AP (A-rated, therapeutically equivalent) | June 15, 2022 | 2.5MG/ML |
| FRESENIUS KABI USA LLC | 216471 | AP (A-rated, therapeutically equivalent) | April 23, 2024 | 2.5MG/ML |
| ASPIRO PHARMA LTD | 218218 | AP (A-rated, therapeutically equivalent) | November 13, 2025 | 2.5MG/ML |
| KNACK PHARMACEUTICALS INC | 220076 | AP (A-rated, therapeutically equivalent) | July 22, 2026 | 2.5MG/ML |
Questions
Is there a generic for Isoptin?
Yes. The generic name for Isoptin is verapamil. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
What is the generic name for Isoptin?
The active ingredient in Isoptin is verapamil, 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.