Divalproex Sodium

Product NDC
68382-134
11-digit product format
683820134
Labeler code
68382
Product ID
68382-134_1881b0e4-109a-47b2-a1e7-b900da6dcf7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA078239
Marketing category
ANDA
Marketing start
2013-01-07
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-134-0168382013401100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-134-01) 2013-01-070000-00-00NoNoCurrent
68382-134-0568382013405500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-134-05) 2013-01-070000-00-00NoNoCurrent
68382-134-166838201341690 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-134-16) 2013-01-070000-00-00NoNoCurrent