FDA Orange Book
Generic for Remeron
Remeron contains mirtazapine. 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 Remeron is mirtazapine. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Remeron products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 15MG | Marketed (Rx) | AB | 10 | AB |
| tablet, oral | 30MG | Marketed (Rx) | AB | 10 | AB |
| tablet, oral | 45MG | Discontinued | None | 10 | AB |
NDA 020415, held by ORGANON USA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic mirtazapine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 076119 | AB (A-rated, therapeutically equivalent) | January 24, 2003 | 15MG, 30MG, 45MG |
| CHARTWELL RX SCIENCES LLC | 076219 | AB (A-rated, therapeutically equivalent) | June 19, 2003 | 15MG, 30MG, 45MG |
| MYLAN PHARMACEUTICALS INC | 076122 | AB (A-rated, therapeutically equivalent) | June 19, 2003 | 15MG, 30MG, 45MG |
| SUN PHARMACEUTICAL INDUSTRIES INC | 076541 | AB (A-rated, therapeutically equivalent) | April 22, 2004 | 15MG, 30MG, 45MG |
| AUROBINDO PHARMA LTD | 076921 | AB (A-rated, therapeutically equivalent) | October 22, 2004 | 15MG, 30MG, 45MG |
| APOTEX INC | 077666 | AB (A-rated, therapeutically equivalent) | August 22, 2007 | 15MG, 30MG, 45MG |
| PRASCO LLC DBA PRASCO LABORATORIES | 216751 | AB (A-rated, therapeutically equivalent) | January 18, 2023 | 15MG, 30MG, 45MG |
| ANNORA PHARMA PRIVATE LTD | 219721 | AB (A-rated, therapeutically equivalent) | October 2, 2025 | 15MG, 30MG, 45MG |
| NOVITIUM PHARMA LLC | 219919 | AB (A-rated, therapeutically equivalent) | February 2, 2026 | 15MG, 30MG, 45MG |
| MICRO LABS LTD | 220104 | AB (A-rated, therapeutically equivalent) | May 19, 2026 | 15MG, 30MG, 45MG |
Remeron NDC codes
Questions
Is there a generic for Remeron?
Yes. The generic name for Remeron is mirtazapine. 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 Remeron?
The active ingredient in Remeron is mirtazapine, 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.