FDA Orange Book
Generic for Cordarone
Cordarone contains amiodarone. 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 Cordarone is amiodarone. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
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Cordarone products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 50MG/ML | Discontinued | None | 7 | AP |
| tablet, oral | 200MG | Discontinued | None | 9 | AB |
NDA 020377, 018972, held by WYETH PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic amiodarone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| UPSHER SMITH LABORATORIES LLC | 075135 | AB (A-rated, therapeutically equivalent) | April 30, 1998 | 200MG |
| TEVA PHARMACEUTICALS USA | 074739 | AB (A-rated, therapeutically equivalent) | November 30, 1998 | 200MG |
| DR REDDYS LABORATORIES SA | 075389 | AB (A-rated, therapeutically equivalent) | January 25, 2001 | 200MG |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 075424 | AB (A-rated, therapeutically equivalent) | March 30, 2001 | 200MG |
| FRESENIUS KABI USA LLC | 075761 | AP (A-rated, therapeutically equivalent) | October 15, 2002 | 50MG/ML |
| MYLAN INSTITUTIONAL LLC | 076217 | AP (A-rated, therapeutically equivalent) | October 15, 2002 | 50MG/ML |
| CHARTWELL RX SCIENCES LLC | 077069 | AB (A-rated, therapeutically equivalent) | April 8, 2005 | 200MG |
| GLAND PHARMA LTD | 077161 | AP (A-rated, therapeutically equivalent) | April 20, 2005 | 50MG/ML |
| HIKMA FARMACEUTICA (PORTUGAL) SA | 077234 | AP (A-rated, therapeutically equivalent) | February 25, 2008 | 50MG/ML |
| ZYDUS PHARMACEUTICALS USA INC | 079029 | AB (A-rated, therapeutically equivalent) | September 16, 2008 | 200MG |
| ACELLA PHARMACEUTICALS LLC | 077610 | AP (A-rated, therapeutically equivalent) | October 30, 2008 | 50MG/ML |
| ACELLA PHARMACEUTICALS LLC | 077834 | AP (A-rated, therapeutically equivalent) | October 30, 2008 | 50MG/ML |
| RUBICON RESEARCH LTD | 078578 | AB (A-rated, therapeutically equivalent) | November 6, 2008 | 200MG |
| AUROBINDO PHARMA LTD | 204742 | AB (A-rated, therapeutically equivalent) | June 3, 2016 | 200MG |
| UNICHEM LABORATORIES LTD | 213446 | AB (A-rated, therapeutically equivalent) | July 21, 2020 | 200MG |
| ZHEJIANG POLY PHARM CO LTD | 218253 | AP (A-rated, therapeutically equivalent) | September 11, 2024 | 50MG/ML |
Questions
Is there a generic for Cordarone?
Yes. The generic name for Cordarone is amiodarone. 15 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 Cordarone?
The active ingredient in Cordarone is amiodarone, 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.