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Active ingredient

Valproate

228 finished FDA listings contain Valproate as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
DIVALPROEX SODIUM, VALPROATE SODIUM, VALPROIC ACID
Dosage forms
Capsule, Capsule, Coated Pellets, Capsule, Delayed Release, Capsule, Liquid Filled, Injection, Injection, Solution, Pellet, Solution, Tablet, Delayed Release, Tablet, Extended Release, Tablet, Film Coated, Extended Release
Routes
Intravenous, Oral
Manufacturers / labelers
57
Strengths listed
1 [hp_m]/1 · 1 [hp_q]/1 · 10 [hp_m]/1 · 100 [hp_c]/1 · 100 mg/ml · 12 [hp_c]/1 · 125 mg/1 · 200 [hp_c]/1 · 250 mg/1 · 250 mg/5ml · 30 [hp_c]/1 · 500 [hp_c]/1 · 500 mg/1 · 500 mg/10ml · 500 mg/5ml · 6 [hp_c]/1
Brand names in FDA listings
Depakote, Depakote Er, Depakote Sprinkles, Valproic

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 40254

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 018723ABBVIE1983-03-103
ANDA 070868PHARMOBEDIENT CNSLTG1986-07-011
NDA 019680ABBVIE1989-09-121
ANDA 073229CATALENT1991-10-295
ANDA 073178ANI PHARMS1992-08-254
ANDA 073484BIONPHARMA1993-06-296
NDA 021168ABBVIE2000-08-042
ANDA 075379PHARM ASSOC2000-12-159
ANDA 075782CHARTWELL RX2000-12-224
ANDA 076295SAGENT2002-11-141
ANDA 076539FRESENIUS KABI USA2003-06-262
ANDA 078790LUPIN2008-07-293
ANDA 078182UPSHER SMITH LABS2008-07-296
ANDA 078755DR REDDYS LABS LTD2008-07-293
ANDA 078597SUN PHARM INDS2008-07-2923
ANDA 078853ORBION PHARMS2008-11-2513
ANDA 078979DR REDDYS LABS LTD2009-01-235
ANDA 078919ZYDUS PHARMS USA INC2009-01-276
ANDA 077567MYLAN2009-01-298
ANDA 078239ZYDUS PHARMS USA INC2009-02-274
ANDA 078523HIKMA FARMACEUTICA2010-02-172
ANDA 090517QUAGEN2010-05-281
ANDA 079163UNICHEM LABS LTD2011-04-0525
ANDA 090554AUROBINDO PHARMA LTD2011-04-2114
ANDA 090070REDDYS2012-03-122
ANDA 090161DR REDDYS LABS LTD2012-03-154
ANDA 202419AUROBINDO PHARMA LTD2014-06-0216
ANDA 203730AMNEAL PHARMS2015-05-298
ANDA 209286LUPIN2019-10-1810
ANDA 213181AJANTA PHARMA LTD2020-02-282
ANDA 214643UNICHEM2022-02-2512
ANDA 215527ANNORA PHARMA2023-09-263
ANDA 218793ALEMBIC2024-12-192
ANDA 217358MANKIND PHARMA2025-08-122

Official labeling on DailyMed

Showing the 12 most recent of 154 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.