FDA Orange Book
Generic for Lipitor
Lipitor contains atorvastatin. 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 Lipitor is atorvastatin. 21 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Lipitor 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 | 23 | AB |
| tablet, oral | EQ 20MG BASE | Marketed (Rx) | AB | 23 | AB |
| tablet, oral | EQ 40MG BASE | Marketed (Rx) | AB | 23 | AB |
| tablet, oral | EQ 80MG BASE | Marketed (Rx) | AB | 23 | AB |
NDA 020702, held by UPJOHN MANUFACTURING IRELAND UNLTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic atorvastatin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 090548 | AB (A-rated, therapeutically equivalent) | May 29, 2012 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE |
| CHARTWELL RX SCIENCES LLC | 077575 | AB (A-rated, therapeutically equivalent) | May 29, 2012 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE |
| MYLAN PHARMACEUTICALS INC | 091226 | AB (A-rated, therapeutically equivalent) | May 29, 2012 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE |
| DR REDDYS LABORATORIES LTD | 091650 | AB (A-rated, therapeutically equivalent) | July 17, 2012 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE |
| DR REDDYS LABORATORIES LTD | 202357 | AB (A-rated, therapeutically equivalent) | July 17, 2012 | EQ 80MG BASE |
| LANNETT CO INC | 091624 | AB (A-rated, therapeutically equivalent) | April 5, 2013 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE |
| SCIEGEN PHARMACEUTICALS INC | 205519 | AB (A-rated, therapeutically equivalent) | May 19, 2016 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE |
| TEVA PHARMACEUTICALS USA | 205300 | AB (A-rated, therapeutically equivalent) | March 27, 2017 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE |
| ACCORD HEALTHCARE INC | 207687 | AB (A-rated, therapeutically equivalent) | March 30, 2018 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE |
| GRAVITI PHARMACEUTICALS PRIVATE LTD | 209912 | AB (A-rated, therapeutically equivalent) | June 18, 2018 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE |
| ZYDUS PHARMACEUTICALS USA INC | 206536 | AB (A-rated, therapeutically equivalent) | November 20, 2018 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE |
| ALKEM LABORATORIES LTD | 209288 | AB (A-rated, therapeutically equivalent) | December 21, 2018 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE |
| MSN LABORATORIES PRIVATE LTD | 211933 | AB (A-rated, therapeutically equivalent) | February 8, 2019 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE |
| UMEDICA LABORATORIES PRIVATE LTD | 213853 | AB (A-rated, therapeutically equivalent) | August 19, 2020 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE |
| DR REDDYS LABORATORIES LTD | 214659 | AB (A-rated, therapeutically equivalent) | July 14, 2021 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE |
| APOTEX INC | 214969 | AB (A-rated, therapeutically equivalent) | September 2, 2021 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE |
| BIOCON PHARMA LTD | 216436 | AB (A-rated, therapeutically equivalent) | November 23, 2022 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE |
| HETERO LABS LTD UNIT V | 214344 | AB (A-rated, therapeutically equivalent) | September 12, 2023 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE |
| MANKIND PHARMA LTD | 217081 | AB (A-rated, therapeutically equivalent) | January 5, 2024 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE |
| LAURUS LABS LTD | 214513 | AB (A-rated, therapeutically equivalent) | January 22, 2024 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE |
| SHANDONG XINHUA PHARMACEUTICAL CO LTD | 211886 | AB (A-rated, therapeutically equivalent) | January 25, 2024 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE |
| AUROBINDO PHARMA LTD | 217118 | AB (A-rated, therapeutically equivalent) | February 13, 2024 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE |
| MACLEODS PHARMACEUTICALS LTD | 208480 | AB (A-rated, therapeutically equivalent) | June 3, 2024 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE |
| TEVA PHARMACEUTICALS INC | 220276 | AB (A-rated, therapeutically equivalent) | November 13, 2025 | EQ 10MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE |
Lipitor NDC codes
Questions
Is there a generic for Lipitor?
Yes. The generic name for Lipitor is atorvastatin. 21 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 Lipitor?
The active ingredient in Lipitor is atorvastatin, 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 Lipitor and Atorvastatin
- What is Lipitor used for?FDA label uses
- Is Lipitor a controlled substance?Federal schedule
- What is Atorvastatin used for?FDA label uses
- Is Atorvastatin a controlled substance?Federal schedule
- Generic for AtorvaliqFDA Orange Book
- Statins listFDA drug class
- Lipitor Medicare Part D coverageBy plan and state
- NDC 58151-155Lipitor NDC record
- NDC 58151-156Lipitor NDC record
- NDC 58151-157Lipitor NDC record