FDA Orange Book
Generic for Depakote ER
Depakote ER contains divalproex. 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 Depakote ER is divalproex. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Depakote ER and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Depakote ER products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | EQ 250MG VALPROIC ACID | Marketed (Rx) | AB | 9 | AB |
| tablet, extended release, oral | EQ 500MG VALPROIC ACID | Marketed (Rx) | AB | 9 | AB |
NDA 021168, 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 divalproex
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 077567 | AB (A-rated, therapeutically equivalent) | January 29, 2009 | EQ 250MG VALPROIC ACID, EQ 500MG VALPROIC ACID |
| SCIEGEN PHARMACEUTICALS INC | 078705 | AB (A-rated, therapeutically equivalent) | February 10, 2009 | EQ 250MG VALPROIC ACID, EQ 500MG VALPROIC ACID |
| ZYDUS PHARMACEUTICALS USA INC | 078239 | AB (A-rated, therapeutically equivalent) | February 27, 2009 | EQ 250MG VALPROIC ACID, EQ 500MG VALPROIC ACID |
| DOCTOR REDDYS LABORATORIES LTD | 090070 | AB (A-rated, therapeutically equivalent) | March 12, 2012 | EQ 500MG VALPROIC ACID |
| DR REDDYS LABORATORIES LTD | 090161 | AB (A-rated, therapeutically equivalent) | March 15, 2012 | EQ 250MG VALPROIC ACID |
| AUROBINDO PHARMA LTD | 202419 | AB (A-rated, therapeutically equivalent) | June 2, 2014 | EQ 250MG VALPROIC ACID, EQ 500MG VALPROIC ACID |
| AMNEAL PHARMACEUTICALS | 203730 | AB (A-rated, therapeutically equivalent) | May 29, 2015 | EQ 250MG VALPROIC ACID, EQ 500MG VALPROIC ACID |
| LUPIN LTD | 209286 | AB (A-rated, therapeutically equivalent) | October 18, 2019 | EQ 250MG VALPROIC ACID, EQ 500MG VALPROIC ACID |
| UNICHEM LABORATORIES LTD | 214643 | AB (A-rated, therapeutically equivalent) | February 25, 2022 | EQ 250MG VALPROIC ACID, EQ 500MG VALPROIC ACID |
| ANNORA PHARMA PRIVATE LTD | 215527 | AB (A-rated, therapeutically equivalent) | September 26, 2023 | EQ 250MG VALPROIC ACID, EQ 500MG VALPROIC ACID |
Depakote ER NDC codes
Questions
Is there a generic for Depakote ER?
Yes. The generic name for Depakote ER is divalproex. 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 Depakote ER?
The active ingredient in Depakote ER is divalproex, 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.