Divalproex sodium

Product NDC
70518-2003
11-digit product format
705182003
Labeler code
70518
Product ID
70518-2003_eeb57829-dc7b-6e70-e053-2995a90a7de8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202419
Marketing category
ANDA
Marketing start
2019-04-08
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2003-07051820030030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-2003-0) 2019-04-080000-00-00NoNoCurrent
70518-2003-170518200301100 POUCH in 1 BOX (70518-2003-1) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 POUCH (70518-2003-2) 100 pouch2019-12-090000-00-00NoNoCurrent