FDA Orange Book
Generic for Singulair
Singulair contains montelukast. 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 Singulair is montelukast. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Singulair products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| granule, oral | EQ 4MG BASE/PACKET | Discontinued | None | 4 | AB |
| tablet, chewable, oral | EQ 4MG BASE | Discontinued | None | 12 | AB |
| tablet, chewable, oral | EQ 5MG BASE | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | EQ 10MG BASE | Marketed (Rx) | AB | 16 | AB |
NDA 021409, 020830, 020829, 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 montelukast
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA LTD | 202096 | AB (A-rated, therapeutically equivalent) | August 3, 2012 | EQ 4MG BASE, EQ 5MG BASE |
| LANNETT CO INC | 200405 | AB (A-rated, therapeutically equivalent) | August 3, 2012 | EQ 4MG BASE, EQ 5MG BASE |
| TEVA PHARMACEUTICALS USA | 078723 | AB (A-rated, therapeutically equivalent) | August 3, 2012 | EQ 4MG BASE, EQ 5MG BASE |
| TORRENT PHARMACEUTICALS LTD | 090984 | AB (A-rated, therapeutically equivalent) | August 3, 2012 | EQ 4MG BASE, EQ 5MG BASE |
| AIPING PHARMACEUTICAL INC | 200889 | AB (A-rated, therapeutically equivalent) | August 3, 2012 | EQ 10MG BASE |
| AUROBINDO PHARMA LTD | 202468 | AB (A-rated, therapeutically equivalent) | August 3, 2012 | EQ 10MG BASE |
| CHARTWELL MOLECULAR HOLDINGS LLC | 201522 | AB (A-rated, therapeutically equivalent) | August 3, 2012 | EQ 10MG BASE |
| GLENMARK PHARMACEUTICALS LTD | 090926 | AB (A-rated, therapeutically equivalent) | August 3, 2012 | EQ 10MG BASE |
| TEVA PHARMACEUTICALS USA | 078605 | AB (A-rated, therapeutically equivalent) | August 3, 2012 | EQ 10MG BASE |
| TORRENT PHARMACEUTICALS LTD | 201515 | AB (A-rated, therapeutically equivalent) | August 3, 2012 | EQ 10MG BASE |
| PHARMAZONE | 201581 | AB (A-rated, therapeutically equivalent) | August 6, 2012 | EQ 4MG BASE, EQ 5MG BASE |
| DR REDDYS LABORATORIES LTD | 201582 | AB (A-rated, therapeutically equivalent) | August 6, 2012 | EQ 10MG BASE |
| DR REDDYS LABORATORIES LTD | 202906 | AB (A-rated, therapeutically equivalent) | September 17, 2012 | EQ 4MG BASE/PACKET |
| ACCORD HEALTHCARE INC | 202717 | AB (A-rated, therapeutically equivalent) | September 21, 2012 | EQ 10MG BASE |
| HETERO LABS LTD UNIT V | 202843 | AB (A-rated, therapeutically equivalent) | September 10, 2014 | EQ 10MG BASE |
| MACLEODS PHARMACEUTICALS LTD | 203366 | AB (A-rated, therapeutically equivalent) | September 11, 2014 | EQ 10MG BASE |
| PHARMOBEDIENT CONSULTING LLC | 203037 | AB (A-rated, therapeutically equivalent) | October 30, 2014 | EQ 4MG BASE, EQ 5MG BASE |
| PHARMOBEDIENT CONSULTING LLC | 202859 | AB (A-rated, therapeutically equivalent) | October 30, 2014 | EQ 10MG BASE |
| MACLEODS PHARMACEUTICALS LTD | 203582 | AB (A-rated, therapeutically equivalent) | March 12, 2015 | EQ 4MG BASE, EQ 5MG BASE |
| HETERO LABS LTD UNIT V | 204093 | AB (A-rated, therapeutically equivalent) | May 22, 2015 | EQ 4MG BASE, EQ 5MG BASE |
| AJANTA PHARMA LTD | 203438 | AB (A-rated, therapeutically equivalent) | July 31, 2015 | EQ 4MG BASE/PACKET |
| AMNEAL PHARMACEUTICALS | 204604 | AB (A-rated, therapeutically equivalent) | September 4, 2015 | EQ 10MG BASE |
| UNICHEM LABORATORIES LTD | 204290 | AB (A-rated, therapeutically equivalent) | October 8, 2015 | EQ 10MG BASE |
| ANBISON LABORATORY CO LTD | 205695 | AB (A-rated, therapeutically equivalent) | November 5, 2015 | EQ 4MG BASE, EQ 5MG BASE |
| ANBISON LABORATORY CO LTD | 205683 | AB (A-rated, therapeutically equivalent) | January 12, 2016 | EQ 10MG BASE |
| CIPLA LTD | 207463 | AB (A-rated, therapeutically equivalent) | October 28, 2016 | EQ 10MG BASE |
| RISING PHARMA HOLDINGS INC | 209011 | AB (A-rated, therapeutically equivalent) | April 18, 2017 | EQ 4MG BASE, EQ 5MG BASE |
| RISING PHARMA HOLDINGS INC | 209012 | AB (A-rated, therapeutically equivalent) | April 24, 2017 | EQ 10MG BASE |
| UNICHEM LABORATORIES LTD | 208621 | AB (A-rated, therapeutically equivalent) | July 2, 2018 | EQ 4MG BASE, EQ 5MG BASE |
| TORRENT PHARMACEUTICALS LTD | 210431 | AB (A-rated, therapeutically equivalent) | July 31, 2018 | EQ 4MG BASE/PACKET |
| CHARTWELL MOLECULAR HOLDINGS LLC | 207464 | AB (A-rated, therapeutically equivalent) | December 6, 2018 | EQ 4MG BASE, EQ 5MG BASE |
| AUROBINDO PHARMA LTD | 213471 | AB (A-rated, therapeutically equivalent) | February 18, 2020 | EQ 4MG BASE/PACKET |
Singulair NDC codes
Questions
Is there a generic for Singulair?
Yes. The generic name for Singulair is montelukast. 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 Singulair?
The active ingredient in Singulair is montelukast, 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 Singulair and Montelukast
- What is Singulair used for?FDA label uses
- Is Singulair a controlled substance?Federal schedule
- What is Montelukast used for?FDA label uses
- Is Montelukast a controlled substance?Federal schedule
- Leukotriene Receptor Antagonists listFDA drug class
- NDC 78206-170Singulair NDC record
- NDC 78206-171Singulair NDC record
- NDC 78206-172Singulair NDC record