FDA Orange Book
Generic for Namenda
Namenda contains memantine. 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 Namenda is memantine. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
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Namenda products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 2MG/ML | Discontinued | None | 4 | AA |
| tablet, oral | 10MG | Discontinued | None | 16 | AB |
| tablet, oral | 5MG | Discontinued | None | 16 | AB |
NDA 021627, 021487, held by ALLERGAN SALES LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic memantine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES LTD | 090048 | AB (A-rated, therapeutically equivalent) | April 14, 2010 | 10MG, 5MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 090058 | AB (A-rated, therapeutically equivalent) | May 5, 2010 | 10MG, 5MG |
| AMNEAL PHARMACEUTICALS OF NEW YORK LLC | 090041 | AB (A-rated, therapeutically equivalent) | April 10, 2015 | 10MG, 5MG |
| LUPIN LTD | 090051 | AB (A-rated, therapeutically equivalent) | April 10, 2015 | 10MG, 5MG |
| UPSHER SMITH LABORATORIES LLC | 090043 | AB (A-rated, therapeutically equivalent) | July 31, 2015 | 10MG, 5MG |
| CHARTWELL MOLECULAR HOLDINGS LLC | 204033 | AA (A-rated, therapeutically equivalent) | October 13, 2015 | 2MG/ML |
| MACLEODS PHARMACEUTICALS LTD | 202790 | AA (A-rated, therapeutically equivalent) | October 13, 2015 | 2MG/ML |
| ALEMBIC PHARMACEUTICALS LTD | 200891 | AB (A-rated, therapeutically equivalent) | October 13, 2015 | 10MG, 5MG |
| AUROBINDO PHARMA LTD | 203175 | AB (A-rated, therapeutically equivalent) | October 13, 2015 | 10MG, 5MG |
| MACLEODS PHARMACEUTICALS LTD | 202840 | AB (A-rated, therapeutically equivalent) | October 13, 2015 | 10MG, 5MG |
| UNICHEM LABORATORIES LTD | 200022 | AB (A-rated, therapeutically equivalent) | October 13, 2015 | 10MG, 5MG |
| PURACAP PHARMACEUTICAL LLC | 206855 | AB (A-rated, therapeutically equivalent) | November 17, 2015 | 10MG, 5MG |
| AJANTA PHARMA LTD | 206528 | AB (A-rated, therapeutically equivalent) | November 30, 2015 | 10MG, 5MG |
| ZYDUS LIFESCIENCES LTD | 090961 | AB (A-rated, therapeutically equivalent) | July 10, 2017 | 10MG, 5MG |
| APOTEX INC | 209955 | AA (A-rated, therapeutically equivalent) | February 9, 2018 | 2MG/ML |
| SOMERSET THERAPEUTICS LLC | 209527 | AB (A-rated, therapeutically equivalent) | May 7, 2018 | 10MG, 5MG |
| PHARMOBEDIENT CONSULTING LLC | 212947 | AB (A-rated, therapeutically equivalent) | April 3, 2020 | 10MG, 5MG |
| PHARMAZONE | 210319 | AA (A-rated, therapeutically equivalent) | August 31, 2020 | 2MG/ML |
| PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 210587 | AB (A-rated, therapeutically equivalent) | December 11, 2020 | 10MG, 5MG |
| HETERO LABS LTD UNIT V | 204389 | AB (A-rated, therapeutically equivalent) | September 26, 2022 | 10MG, 5MG |
Namenda NDC codes
Questions
Is there a generic for Namenda?
Yes. The generic name for Namenda is memantine. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
What is the generic name for Namenda?
The active ingredient in Namenda is memantine, 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.