FDA Orange Book
Generic for Depakene
Depakene contains valproic acid. 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 Depakene is valproic acid. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
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Depakene products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 250MG | Discontinued | None | 2 | AB |
| syrup, oral | 250MG/5ML | Discontinued | None | 4 | AA |
NDA 018081, 018082, 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 valproic acid
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CATALENT PHARMA SOLUTIONS LLC | 073229 | AB (A-rated, therapeutically equivalent) | October 29, 1991 | 250MG |
| ANI PHARMACEUTICALS INC | 073178 | AA (A-rated, therapeutically equivalent) | August 25, 1992 | 250MG/5ML |
| BIONPHARMA INC | 073484 | AB (A-rated, therapeutically equivalent) | June 29, 1993 | 250MG |
| PHARMACEUTICAL ASSOCIATES INC | 075379 | AA (A-rated, therapeutically equivalent) | December 15, 2000 | 250MG/5ML |
| CHARTWELL RX SCIENCES LLC | 075782 | AA (A-rated, therapeutically equivalent) | December 22, 2000 | 250MG/5ML |
| QUAGEN PHARMACEUTICALS LLC | 090517 | AA (A-rated, therapeutically equivalent) | May 28, 2010 | 250MG/5ML |
Questions
Is there a generic for Depakene?
Yes. The generic name for Depakene is valproic acid. 6 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 Depakene?
The active ingredient in Depakene is valproic acid, 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.