FDA Orange Book · active-ingredient family
Divalproex sodium
Divalproex sodium: 4 brands, 38 generics; first approved Mar 10, 1983; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 38 ANDA applications approved.
Brands (NDA)
4
Generics (ANDA)
38
Listed patents
0
Presentations
87
Brand (NDA) products
Originator applications
- DEPAKOTE ERRLDABBVIENDA 02116820022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Rx AB EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Rx AB - ABBVIENDA 0196801989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS ORAL Rx AB - DEPAKOTERLDABBVIENDA 01872319843 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB EQ 500MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB EQ 125MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB - ABBOTTNDA 01979419902 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET, DELAYED RELEASE ORAL Discontinued — EQ 500MG BASE TABLET, DELAYED RELEASE ORAL Discontinued —
Generic (ANDA) products (38)
Abbreviated applications
- DIVALPROEX SODIUMMANKIND PHARMAANDA 2173582025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS ORAL Rx AB - DIVALPROEX SODIUMALEMBICANDA 2187932024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS ORAL Rx AB - DIVALPROEX SODIUMANNORA PHARMAANDA 21552720232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Rx AB EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Rx AB - DIVALPROEX SODIUMUNICHEMANDA 21464320222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Rx AB EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Rx AB - DIVALPROEX SODIUMYICHANG HUMANWELLANDA 21446220212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Discontinued — - DIVALPROEX SODIUMTEVA PHARMS USAANDA 2115052020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS ORAL Discontinued — - DIVALPROEX SODIUMAJANTA PHARMA LTDANDA 2131812020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS ORAL Rx AB - DIVALPROEX SODIUMLUPINANDA 20928620192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Rx AB EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Rx AB - DIVALPROEX SODIUMAMNEAL PHARMSANDA 20373020152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Rx AB EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Rx AB - DIVALPROEX SODIUMAUROBINDO PHARMA LTDANDA 20241920142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Rx AB EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Rx AB - DIVALPROEX SODIUMDR REDDYS LABS LTDANDA 0901612012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Rx AB - DIVALPROEX SODIUMREDDYSANDA 0900702012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Rx AB - DIVALPROEX SODIUMAUROBINDO PHARMA LTDANDA 09055420113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB EQ 250MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB EQ 500MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB - DIVALPROEX SODIUMUNICHEM LABS LTDANDA 07916320113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB EQ 250MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB EQ 500MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB - DIVALPROEX SODIUMRISINGANDA 0904072011
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS ORAL Discontinued — - DIVALPROEX SODIUMACTAVIS LABS FL INCANDA 0790802011
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Discontinued — - DIVALPROEX SODIUMPRINSTON INCANDA 09021020093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB EQ 250MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB EQ 500MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB - DIVALPROEX SODIUMCOSETTE PHARMS NCANDA 0787002009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Discontinued — - DIVALPROEX SODIUMIMPAX LABSANDA 07879120092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Discontinued — - DIVALPROEX SODIUMPHARMOBEDIENTANDA 09006220093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Discontinued — EQ 250MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Discontinued — EQ 500MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Discontinued — - DIVALPROEX SODIUMZYDUS PHARMS USA INCANDA 07710020093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB EQ 250MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB EQ 500MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB - DIVALPROEX SODIUMZYDUS PHARMS USA INCANDA 07823920092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Rx AB EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Rx AB - DIVALPROEX SODIUMPH HEALTHANDA 07844520092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Discontinued — - DIVALPROEX SODIUMSCIEGEN PHARMSANDA 07870520092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Rx AB EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Rx AB - DIVALPROEX SODIUMMYLANANDA 07756720092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Rx AB EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE ORAL Rx AB - DIVALPROEX SODIUMZYDUS PHARMS USA INCANDA 0789192009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS ORAL Rx AB - DIVALPROEX SODIUMDR REDDYS LABS LTDANDA 0789792009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS ORAL Rx AB - DIVALPROEX SODIUMORBION PHARMSANDA 07885320083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB EQ 250MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB EQ 500MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB - DIVALPROEX SODIUMPH HEALTHANDA 0784112008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Discontinued — - DIVALPROEX SODIUMCHARTWELL RXANDA 07729620083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB EQ 250MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB EQ 500MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB - DIVALPROEX SODIUMAPOTEXANDA 07761520083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Discontinued — EQ 250MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Discontinued — EQ 125MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Discontinued — - DIVALPROEX SODIUMDR REDDYS LABS LTDANDA 07875520083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB EQ 250MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB EQ 500MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB - DIVALPROEX SODIUMINVATECHANDA 07829020083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB EQ 250MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB EQ 125MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB - DIVALPROEX SODIUMLUPINANDA 07879020083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Discontinued — EQ 250MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Discontinued — EQ 500MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Discontinued — - DIVALPROEX SODIUMMYLANANDA 07725420083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Discontinued — EQ 250MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Discontinued — EQ 500MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Discontinued — - DIVALPROEX SODIUMSUN PHARM INDSANDA 07859720083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB EQ 250MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB EQ 500MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB - DIVALPROEX SODIUMTEVAANDA 07694120083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Discontinued — EQ 250MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Discontinued — EQ 500MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Discontinued — - DIVALPROEX SODIUMUPSHER SMITH LABSANDA 07818220083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB EQ 250MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB EQ 500MG VALPROIC ACID TABLET, DELAYED RELEASE ORAL Rx AB
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
44 yr 1 mo ago
Most recent approval
1 yr ago
Approvals span 1983–2025 across 42 FDA applications.
Brand (NDA) 410%
Generic (ANDA) 3890%
Divalproex sodium: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
