DailyMed - DIVALPROEX SODIUM tablet, film coated, extended release

NDC Code(s): 65841-637-01, 65841-637-05, 65841-637-14, 65841-637-16, view more
65841-638-01, 65841-638-05, 65841-638-16
Packager: Zydus Lifesciences Limited

Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 2, 2025

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SPL MEDGUIDE
Manufactured by: Cadila Healthcare Ltd. India.

Manufactured by:

Cadila Healthcare Ltd.

India.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-637-01 in bottle of 100 tablets - Divalproex Sodium ER Tablets, 250 mg - Rx only - 100 tablets - NDC 65841-638-01 in bottle of 100 tablets - Divalproex Sodium ER Tablets, 500 mg - Rx only - 100 ...

NDC 65841-637-01 in bottle of 100 tablets

Divalproex Sodium ER Tablets, 250 mg

Rx only

100 tablets

NDC 65841-638-01 in bottle of 100 tablets

Divalproex Sodium ER Tablets, 500 mg

Rx only

100 tablets

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INGREDIENTS AND APPEARANCE

Product Information

DIVALPROEX SODIUM divalproex sodium tablet, film coated, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-637
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIVALPROEX SODIUM (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI)	VALPROIC ACID	250 mg

Ingredient Name	Strength
Inactive Ingredients
AMMONIA (UNII: 5138Q19F1X)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	18mm
Flavor		Imprint Code	ZA47
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-637-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	01/07/2013	03/25/2025
2	NDC:65841-637-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/07/2013	03/25/2025
3	NDC:65841-637-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/07/2013	03/25/2025
4	NDC:65841-637-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/07/2013	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078239	01/07/2013	04/02/2025

DIVALPROEX SODIUM divalproex sodium tablet, film coated, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-638
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIVALPROEX SODIUM (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI)	VALPROIC ACID	500 mg

Ingredient Name	Strength
Inactive Ingredients
AMMONIA (UNII: 5138Q19F1X)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	23mm
Flavor		Imprint Code	ZA48
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-638-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/07/2013
2	NDC:65841-638-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/07/2013
3	NDC:65841-638-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/07/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078239	01/07/2013

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(65841-637, 65841-638) , MANUFACTURE(65841-637, 65841-638)

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Published Date (What is this?)	Version	Files
Apr 9, 2025	8 (current)	download
Dec 2, 2024	7	download
Oct 17, 2022	6	download
Aug 26, 2020	5	download
Mar 29, 2019	4	download
Mar 27, 2018	3	download
Nov 14, 2017	2	download
Jul 1, 2013	1	download

Published Date (What is this?)

Version

Files

Apr 9, 2025

8 (current)

download

Dec 2, 2024

download

Oct 17, 2022

download

Aug 26, 2020

download

Mar 29, 2019

download

Mar 27, 2018

download

Nov 14, 2017

download

Jul 1, 2013

download

	RxCUI	RxNorm NAME	RxTTY
1	1099563	divalproex sodium 250 MG 24HR Extended Release Oral Tablet	PSN
2	1099563	24 HR divalproex sodium 250 MG Extended Release Oral Tablet	SCD
3	1099563	divalproex sodium 250 MG 24 HR Extended Release Oral Tablet	SY
4	1099569	divalproex sodium 500 MG 24HR Extended Release Oral Tablet	PSN
5	1099569	24 HR divalproex sodium 500 MG Extended Release Oral Tablet	SCD
6	1099569	divalproex sodium 500 MG 24 HR Extended Release Oral Tablet	SY

Label: DIVALPROEX SODIUM tablet, film coated, extended release

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	NDC
1	65841-637-01
2	65841-637-05
3	65841-637-14
4	65841-637-16
5	65841-638-01
6	65841-638-05
7	65841-638-16

Label: DIVALPROEX SODIUM tablet, film coated, extended release

View Package Photos

Drug Label Info

Safety

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Drug Label Information

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Safety

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More Info on this Drug

DIVALPROEX SODIUM tablet, film coated, extended release

Number of versions: 8

DIVALPROEX SODIUM tablet, film coated, extended release

DIVALPROEX SODIUM tablet, film coated, extended release

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DIVALPROEX SODIUM tablet, film coated, extended release

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.