FDA Orange Book
Generic for Pravachol
Pravachol contains pravastatin. 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 Pravachol is pravastatin. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Pravachol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Discontinued | None | 11 | AB |
| tablet, oral | 20MG | Discontinued | None | 12 | AB |
| tablet, oral | 40MG | Discontinued | None | 12 | AB |
| tablet, oral | 80MG | Discontinued | None | 12 | AB |
NDA 019898, held by BRISTOL MYERS SQUIBB. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic pravastatin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA USA INC | 076056 | AB (A-rated, therapeutically equivalent) | April 24, 2006 | 10MG, 20MG, 40MG |
| APOTEX INC | 076341 | AB (A-rated, therapeutically equivalent) | October 23, 2006 | 10MG, 20MG, 40MG, 80MG |
| CIPLA LTD | 077904 | AB (A-rated, therapeutically equivalent) | October 23, 2006 | 10MG, 20MG, 40MG, 80MG |
| DR REDDYS LABORATORIES INC | 076714 | AB (A-rated, therapeutically equivalent) | October 23, 2006 | 10MG, 20MG, 40MG, 80MG |
| PHARMAZONE | 077491 | AB (A-rated, therapeutically equivalent) | October 23, 2006 | 10MG, 20MG, 40MG, 80MG |
| WATSON LABORATORIES INC | 076939 | AB (A-rated, therapeutically equivalent) | October 23, 2006 | 10MG, 20MG, 40MG, 80MG |
| GLENMARK PHARMACEUTICALS LTD | 077987 | AB (A-rated, therapeutically equivalent) | May 11, 2007 | 10MG, 20MG, 40MG, 80MG |
| CHARTWELL RX SCIENCES LLC | 077917 | AB (A-rated, therapeutically equivalent) | January 8, 2008 | 10MG, 20MG, 40MG, 80MG |
| AUROBINDO PHARMA USA INC | 077793 | AB (A-rated, therapeutically equivalent) | January 15, 2008 | 80MG |
| ZYDUS PHARMACEUTICALS USA INC | 077751 | AB (A-rated, therapeutically equivalent) | April 30, 2008 | 20MG, 40MG, 80MG |
| ACCORD HEALTHCARE INC | 207068 | AB (A-rated, therapeutically equivalent) | November 17, 2016 | 10MG, 20MG, 40MG, 80MG |
| AUROBINDO PHARMA LTD | 203367 | AB (A-rated, therapeutically equivalent) | February 2, 2017 | 10MG, 20MG, 40MG, 80MG |
| BIOCON PHARMA INC | 209869 | AB (A-rated, therapeutically equivalent) | April 13, 2018 | 10MG, 20MG, 40MG, 80MG |
Questions
Is there a generic for Pravachol?
Yes. The generic name for Pravachol is pravastatin. 12 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 Pravachol?
The active ingredient in Pravachol is pravastatin, 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.