FDA Orange Book
Generic for Rozerem
Rozerem contains ramelteon. 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 Rozerem is ramelteon. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Rozerem products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 8MG | Marketed (Rx) | AB | 10 | AB |
NDA 021782, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ramelteon
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES SA | 091693 | AB (A-rated, therapeutically equivalent) | July 26, 2013 | 8MG |
| ACTAVIS LABORATORIES FL INC | 091610 | AB (A-rated, therapeutically equivalent) | August 19, 2015 | 8MG |
| ZYDUS PHARMACEUTICALS USA INC | 211567 | AB (A-rated, therapeutically equivalent) | July 22, 2019 | 8MG |
| PHARMAZONE | 212650 | AB (A-rated, therapeutically equivalent) | April 10, 2020 | 8MG |
| APPCO PHARMA LLC | 213815 | AB (A-rated, therapeutically equivalent) | October 26, 2020 | 8MG |
| ANDAS 5 HOLDING LLC | 215435 | AB (A-rated, therapeutically equivalent) | August 24, 2022 | 8MG |
| XIROMED PHARMA ESPANA SL | 216209 | AB (A-rated, therapeutically equivalent) | November 25, 2022 | 8MG |
| MICRO LABS LTD | 215243 | AB (A-rated, therapeutically equivalent) | February 9, 2023 | 8MG |
| AUROBINDO PHARMA LTD | 215972 | AB (A-rated, therapeutically equivalent) | July 10, 2023 | 8MG |
| ADAPTIS PHARMA PRIVATE LTD | 215485 | AB (A-rated, therapeutically equivalent) | June 4, 2026 | 8MG |
Rozerem NDC codes
Questions
Is there a generic for Rozerem?
Yes. The generic name for Rozerem is ramelteon. 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 Rozerem?
The active ingredient in Rozerem is ramelteon, 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.