FDA Orange Book
Generic for Crestor
Crestor contains rosuvastatin. 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 Crestor is rosuvastatin. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Crestor products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 10MG BASE | Marketed (Rx) | AB | 19 | AB |
| tablet, oral | EQ 20MG BASE | Marketed (Rx) | AB | 19 | AB |
| tablet, oral | EQ 40MG BASE | Marketed (Rx) | AB | 19 | AB |
| tablet, oral | EQ 5MG BASE | Marketed (Rx) | AB | 19 | AB |
NDA 021366, held by ASTRAZENECA UK LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic rosuvastatin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| WATSON LABORATORIES INC | 079167 | AB (A-rated, therapeutically equivalent) | April 29, 2016 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 5MG BASE |
| AUROBINDO PHARMA LTD | 079170 | AB (A-rated, therapeutically equivalent) | July 19, 2016 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 5MG BASE |
| CHARTWELL RX SCIENCES LLC | 079168 | AB (A-rated, therapeutically equivalent) | July 19, 2016 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 5MG BASE |
| GLENMARK SPECIALTY SA | 079172 | AB (A-rated, therapeutically equivalent) | July 19, 2016 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 5MG BASE |
| ACCORD HEALTHCARE INC | 206434 | AB (A-rated, therapeutically equivalent) | October 31, 2016 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 5MG BASE |
| BIOCON PHARMA LTD | 207752 | AB (A-rated, therapeutically equivalent) | October 31, 2016 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 5MG BASE |
| CHANGZHOU PHARMACEUTICAL FACTORY | 207408 | AB (A-rated, therapeutically equivalent) | October 31, 2016 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 5MG BASE |
| HETERO LABS LTD UNIT V | 207616 | AB (A-rated, therapeutically equivalent) | October 31, 2016 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 5MG BASE |
| RENATA PLC | 207062 | AB (A-rated, therapeutically equivalent) | October 31, 2016 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 5MG BASE |
| TORRENT PHARMACEUTICALS LTD | 201619 | AB (A-rated, therapeutically equivalent) | October 31, 2016 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 5MG BASE |
| CADILA PHARMACEUTICALS LTD | 207453 | AB (A-rated, therapeutically equivalent) | November 23, 2016 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 5MG BASE |
| ALKEM LABORATORIES LTD | 206465 | AB (A-rated, therapeutically equivalent) | March 21, 2017 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 5MG BASE |
| MSN LABORATORIES PRIVATE LTD | 208898 | AB (A-rated, therapeutically equivalent) | November 22, 2017 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 5MG BASE |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO LTD | 206513 | AB (A-rated, therapeutically equivalent) | March 1, 2019 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 5MG BASE |
| UMEDICA LABORATORIES PRIVATE LTD | 207626 | AB (A-rated, therapeutically equivalent) | April 9, 2019 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 5MG BASE |
| SCIEGEN PHARMACEUTICALS INC | 206381 | AB (A-rated, therapeutically equivalent) | April 24, 2019 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 5MG BASE |
| SHANDONG NEW TIME PHARMACEUTICAL CO LTD | 207375 | AB (A-rated, therapeutically equivalent) | May 7, 2019 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 5MG BASE |
| ZHEJIANG YONGTAI PHARMACEUTICAL CO LTD | 212059 | AB (A-rated, therapeutically equivalent) | November 4, 2019 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 5MG BASE |
| SUNSHINE LAKE PHARMA CO LTD | 210667 | AB (A-rated, therapeutically equivalent) | April 1, 2020 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 5MG BASE |
Crestor NDC codes
Questions
Is there a generic for Crestor?
Yes. The generic name for Crestor is rosuvastatin. 19 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 Crestor?
The active ingredient in Crestor is rosuvastatin, 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.
More on Crestor and Rosuvastatin
- What is Crestor used for?FDA label uses
- Is Crestor a controlled substance?Federal schedule
- What is Rosuvastatin used for?FDA label uses
- Is Rosuvastatin a controlled substance?Federal schedule
- Statins listFDA drug class
- Crestor Medicare Part D coverageBy plan and state
- NDC 0310-7560Crestor NDC record
- NDC 0310-7570Crestor NDC record
- NDC 0310-7580Crestor NDC record