Divalproex sodium

Product NDC
68788-7177
11-digit product format
687887177
Labeler code
68788
Product ID
68788-7177_c4cc1bf8-dfad-4ccd-8d97-2c3d00871430
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA202419
Marketing category
ANDA
Marketing start
2018-07-17
Marketing end
0000-00-00
Substance
DIVALPROEX SODIUM
Active strength
500 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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7177-3EA - Each68788-71770b6c1dc6-c07b-47a7-8d00-4a2960ef202412018-09-05
68788-7177-6EA - Each68788-717799304f4b-1cb8-4ceb-9fe3-5a6ff011b11512018-09-05
68788-7177-9EA - Each68788-71774af0b29d-5ad8-420b-9eed-d6cbdcae5a6c12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7177DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]8Legacy NDC20240606_4817535e-d9e9-4cc0-9212-e232cbd8c2fd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7177-36878871770330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-7177-3) 2018-07-170000-00-00NoNoCurrent
68788-7177-66878871770660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-7177-6) 2018-07-170000-00-00NoNoCurrent
68788-7177-96878871770990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-7177-9) 2018-07-170000-00-00NoNoCurrent