Divalproex sodium

Product NDC: 63629-7091
11-digit product format: 636297091
Labeler code: 63629
Product ID: 63629-7091_4622fb48-a670-479c-b60f-d3fd62f1312f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Divalproex sodium
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA202419
Marketing category: ANDA
Marketing start: 2014-06-02
Marketing end: 0000-00-00
Substance: DIVALPROEX SODIUM
Active strength: 250 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63629-7091-1	2020-08-27	C162847	48780-1	9d75b9d0-335b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000
63629-7091-1	2020-01-31	C162847	48780-1	9d75b9d0-335b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
644VL95AO6	DIVALPROEX SODIUM	76584-70-8	DIVALPROEX SODIUM

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-7091-1	63629709101	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-7091-1)	2016-09-16	0000-00-00	No	No	Current