FDA Orange Book
Generic for Zocor
Zocor contains simvastatin. 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 Zocor is simvastatin. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Zocor products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Marketed (Rx) | AB | 10 | AB |
| tablet, oral | 20MG | Marketed (Rx) | AB | 10 | AB |
| tablet, oral | 40MG | Marketed (Rx) | AB | 10 | AB |
| tablet, oral | 5MG | Marketed (Rx) | AB | 9 | AB |
| tablet, oral | 80MG | Discontinued | None | 10 | AB |
NDA 019766, held by ORGANON LLC A SUB OF ORGANON AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic simvastatin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA LTD | 077691 | AB (A-rated, therapeutically equivalent) | December 20, 2006 | 10MG, 20MG, 40MG, 5MG, 80MG |
| BIOCON PHARMA LTD | 078034 | AB (A-rated, therapeutically equivalent) | December 20, 2006 | 10MG, 20MG, 40MG, 5MG, 80MG |
| RISING PHARMA HOLDINGS INC | 077752 | AB (A-rated, therapeutically equivalent) | December 20, 2006 | 10MG, 20MG, 40MG, 5MG, 80MG |
| ZYDUS PHARMACEUTICALS USA INC | 077837 | AB (A-rated, therapeutically equivalent) | December 20, 2006 | 10MG, 20MG, 40MG, 5MG, 80MG |
| LUPIN LTD | 078103 | AB (A-rated, therapeutically equivalent) | May 11, 2007 | 10MG, 20MG, 40MG, 5MG, 80MG |
| ACCORD HEALTHCARE INC | 078155 | AB (A-rated, therapeutically equivalent) | February 26, 2008 | 10MG, 20MG, 40MG, 5MG, 80MG |
| TP ANDA HOLDINGS LLC | 078735 | AB (A-rated, therapeutically equivalent) | August 30, 2010 | 10MG, 20MG, 40MG, 5MG, 80MG |
| HETERO LABS LTD UNIT III | 200895 | AB (A-rated, therapeutically equivalent) | November 25, 2014 | 10MG, 20MG, 40MG, 5MG, 80MG |
| INVAGEN PHARMACEUTICALS INC | 206557 | AB (A-rated, therapeutically equivalent) | November 13, 2017 | 10MG, 20MG, 40MG, 5MG, 80MG |
| PHARMOBEDIENT CONSULTING LLC | 211394 | AB (A-rated, therapeutically equivalent) | November 27, 2024 | 10MG, 20MG, 40MG, 80MG |
Zocor NDC codes
Questions
Is there a generic for Zocor?
Yes. The generic name for Zocor is simvastatin. 10 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 Zocor?
The active ingredient in Zocor is simvastatin, 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.