FDA Orange Book
Generic for Paxil CR
Paxil CR contains paroxetine. 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 Paxil CR is paroxetine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Paxil CR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | EQ 12.5MG BASE | Marketed (Rx) | AB | 7 | AB |
| tablet, extended release, oral | EQ 25MG BASE | Marketed (Rx) | AB | 7 | AB |
| tablet, extended release, oral | EQ 37.5MG BASE | Marketed (Rx) | AB | 6 | AB |
NDA 020936, held by APOTEX INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic paroxetine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA USA INC | 077873 | AB (A-rated, therapeutically equivalent) | June 29, 2007 | EQ 12.5MG BASE, EQ 25MG BASE |
| AUROBINDO PHARMA USA INC | 091427 | AB (A-rated, therapeutically equivalent) | April 14, 2011 | EQ 37.5MG BASE |
| LANNETT CO INC | 204744 | AB (A-rated, therapeutically equivalent) | June 10, 2016 | EQ 12.5MG BASE, EQ 25MG BASE, EQ 37.5MG BASE |
| SCIECURE PHARMA INC | 209293 | AB (A-rated, therapeutically equivalent) | June 12, 2018 | EQ 12.5MG BASE, EQ 25MG BASE, EQ 37.5MG BASE |
| CSPC OUYI PHARMACEUTICAL CO LTD | 213485 | AB (A-rated, therapeutically equivalent) | February 16, 2021 | EQ 12.5MG BASE, EQ 25MG BASE, EQ 37.5MG BASE |
| CADILA PHARMACEUTICALS LTD | 212645 | AB (A-rated, therapeutically equivalent) | August 27, 2021 | EQ 12.5MG BASE, EQ 25MG BASE, EQ 37.5MG BASE |
| PRINSTON PHARMACEUTICAL INC | 209748 | AB (A-rated, therapeutically equivalent) | January 4, 2024 | EQ 12.5MG BASE, EQ 25MG BASE |
| ALEMBIC PHARMACEUTICALS LTD | 217280 | AB (A-rated, therapeutically equivalent) | March 26, 2026 | EQ 12.5MG BASE, EQ 25MG BASE, EQ 37.5MG BASE |
Paxil CR NDC codes
Questions
Is there a generic for Paxil CR?
Yes. The generic name for Paxil CR is paroxetine. 7 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 Paxil CR?
The active ingredient in Paxil CR is paroxetine, 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.