FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
70518-2357
11-digit product format
705182357
Labeler code
70518
Product ID
70518-2357_4a04542f-f6a0-59f5-e063-6394a90ab55d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090554
Marketing category
ANDA
Marketing start
2019-10-10
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Divalproex Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIVALPROEX SODIUM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099870

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b10a892b-b985-4cbc-9547-9ac4b72b784fProduct name220250818
7a3a03f1-382a-f9ec-0741-ff24dcbfed69Product name720250624
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
57fc3d01-4737-4091-9728-9e8a4c9e708dProduct name120200121
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5d67ecc7-47c7-ec5e-e9eb-71bf00250645Product name120140508
97fce1a8-50c4-f088-0e31-64d82b6e9081Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2357-0Divalproex Sodium30 in 1 BLISTER PACKTABLET, DELAYED RELEASE3017
70518-2357-1Divalproex Sodium100 in 1 BOXTABLET, DELAYED RELEASE10017
70518-2357-2Divalproex Sodium1 in 1 POUCHTABLET, DELAYED RELEASE117
70518-2357-3Divalproex Sodium100 in 1 BOXTABLET, DELAYED RELEASE10017
70518-2357-4Divalproex Sodium1 in 1 POUCHTABLET, DELAYED RELEASE117
70518-2357-5Divalproex Sodium30 in 1 BLISTER PACKTABLET, DELAYED RELEASE3017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2357DIVALPROEX SODIUM TABLET, DELAYED RELEASE [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 6 package rows20250212_0339e27d-3dbf-4c37-a14e-f53557c08e19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSN0339e27d-3dbf-4c37-a14e-f53557c08e1917
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCD0339e27d-3dbf-4c37-a14e-f53557c08e1917

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2357-07051823570030 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-2357-0) 2019-10-100000-00-00NoNoCurrent
70518-2357-170518235701100 POUCH in 1 BOX (70518-2357-1) / 1 TABLET, DELAYED RELEASE in 1 POUCH (70518-2357-2) 100 pouch2021-03-160000-00-00NoNoCurrent
70518-2357-2705182357021 in 1 POUCHHistorical
70518-2357-370518235703100 POUCH in 1 BOX (70518-2357-3) > 1 TABLET, DELAYED RELEASE in 1 POUCH (70518-2357-4) 100 pouch2021-10-050000-00-00NoNoCurrent
70518-2357-4705182357041 in 1 POUCHHistorical
70518-2357-57051823570530 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-2357-5) 2022-08-090000-00-00NoNoCurrent