FDA Orange Book
Generic for Lexapro
Lexapro contains escitalopram. 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 Lexapro is escitalopram. 14 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
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Lexapro products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | EQ 5MG BASE/5ML | Discontinued | None | 5 | AA |
| tablet, oral | EQ 10MG BASE | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | EQ 20MG BASE | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | EQ 5MG BASE | Marketed (Rx) | AB | 12 | AB |
NDA 021365, 021323, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic escitalopram
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMNEAL PHARMACEUTICALS | 202227 | AA (A-rated, therapeutically equivalent) | March 14, 2012 | EQ 5MG BASE/5ML |
| AUROBINDO PHARMA LTD | 079062 | AA (A-rated, therapeutically equivalent) | April 2, 2012 | EQ 5MG BASE/5ML |
| HETERO LABS LTD UNIT III | 202221 | AA (A-rated, therapeutically equivalent) | June 12, 2012 | EQ 5MG BASE/5ML |
| ACCORD HEALTHCARE INC | 202389 | AB (A-rated, therapeutically equivalent) | September 11, 2012 | EQ 10MG BASE, EQ 20MG BASE, EQ 5MG BASE |
| AUROBINDO PHARMA LTD | 090432 | AB (A-rated, therapeutically equivalent) | September 11, 2012 | EQ 10MG BASE, EQ 20MG BASE, EQ 5MG BASE |
| CHARTWELL RX SCIENCES LLC | 078169 | AB (A-rated, therapeutically equivalent) | September 11, 2012 | EQ 10MG BASE, EQ 20MG BASE, EQ 5MG BASE |
| GRAVITI PHARMACEUTICALS PRIVATE LTD | 078777 | AB (A-rated, therapeutically equivalent) | September 11, 2012 | EQ 10MG BASE, EQ 20MG BASE, EQ 5MG BASE |
| INVAGEN PHARMACEUTICALS INC | 078604 | AB (A-rated, therapeutically equivalent) | September 11, 2012 | EQ 10MG BASE, EQ 20MG BASE, EQ 5MG BASE |
| MACLEODS PHARMACEUTICALS LTD | 202210 | AB (A-rated, therapeutically equivalent) | September 11, 2012 | EQ 10MG BASE, EQ 20MG BASE, EQ 5MG BASE |
| TORRENT PHARMACEUTICALS LTD | 090939 | AB (A-rated, therapeutically equivalent) | September 11, 2012 | EQ 10MG BASE, EQ 20MG BASE, EQ 5MG BASE |
| ZYDUS LIFESCIENCES LTD | 077734 | AB (A-rated, therapeutically equivalent) | September 11, 2012 | EQ 10MG BASE, EQ 20MG BASE, EQ 5MG BASE |
| JUBILANT CADISTA PHARMACEUTICALS INC | 202280 | AB (A-rated, therapeutically equivalent) | September 12, 2012 | EQ 10MG BASE, EQ 20MG BASE, EQ 5MG BASE |
| CHARTWELL MOLECULAR HOLDINGS LLC | 090477 | AA (A-rated, therapeutically equivalent) | June 12, 2013 | EQ 5MG BASE/5ML |
| PRINSTON PHARMACEUTICAL INC | 078032 | AB (A-rated, therapeutically equivalent) | August 28, 2015 | EQ 10MG BASE, EQ 20MG BASE, EQ 5MG BASE |
| MACLEODS PHARMACEUTICALS LTD | 202754 | AA (A-rated, therapeutically equivalent) | March 31, 2016 | EQ 5MG BASE/5ML |
| AMNEAL PHARMACEUTICALS | 205619 | AB (A-rated, therapeutically equivalent) | May 17, 2017 | EQ 10MG BASE, EQ 20MG BASE, EQ 5MG BASE |
| ASCENT PHARMACEUTICALS INC | 215177 | AB (A-rated, therapeutically equivalent) | July 15, 2025 | EQ 10MG BASE, EQ 20MG BASE, EQ 5MG BASE |
Lexapro exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NPP | New patient population | May 12, 2026 | 021365 |
Lexapro NDC codes
Questions
Is there a generic for Lexapro?
Yes. The generic name for Lexapro is escitalopram. 14 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 Lexapro?
The active ingredient in Lexapro is escitalopram, 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 Lexapro and Escitalopram
- What is Lexapro used for?FDA label uses
- Is Lexapro a controlled substance?Federal schedule
- What is Escitalopram used for?FDA label uses
- Is Escitalopram a controlled substance?Federal schedule
- Serotonin Reuptake Inhibitors listFDA drug class
- NDC 0456-2005Lexapro NDC record
- NDC 0456-2010Lexapro NDC record
- NDC 0456-2020Lexapro NDC record