FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
70518-3431
11-digit product format
705183431
Labeler code
70518
Product ID
70518-3431_50b26b52-095d-3033-e063-6394a90a9162
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078597
Marketing category
ANDA
Marketing start
2022-06-03
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
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 SODIUM250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099678

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b10a892b-b985-4cbc-9547-9ac4b72b784fProduct name220250818
7a3a03f1-382a-f9ec-0741-ff24dcbfed69Product name720250624
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
57fc3d01-4737-4091-9728-9e8a4c9e708dProduct name120200121
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5d67ecc7-47c7-ec5e-e9eb-71bf00250645Product name120140508
97fce1a8-50c4-f088-0e31-64d82b6e9081Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3431-0Divalproex Sodium60 in 1 BLISTER PACKTABLET, DELAYED RELEASE609
70518-3431-1Divalproex Sodium30 in 1 BLISTER PACKTABLET, DELAYED RELEASE309
70518-3431-2Divalproex Sodium100 in 1 BOXTABLET, DELAYED RELEASE1009
70518-3431-3Divalproex Sodium1 in 1 POUCHTABLET, DELAYED RELEASE19
70518-3431-4Divalproex Sodium30 in 1 BLISTER PACKTABLET, DELAYED RELEASE309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3431DIVALPROEX SODIUM TABLET, DELAYED RELEASE [REMEDYREPACK INC.]4Current NDC, Legacy NDC, 5 package rows20240628_bb94bbb1-07c1-49be-8c2c-f5635c65366d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNbb94bbb1-07c1-49be-8c2c-f5635c65366d9
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDbb94bbb1-07c1-49be-8c2c-f5635c65366d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3431-07051834310060 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-3431-0) 2022-06-030000-00-00NoNoCurrent
70518-3431-17051834310130 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-3431-1) 2022-06-030000-00-00NoNoCurrent
70518-3431-270518343102100 POUCH in 1 BOX (70518-3431-2) / 1 TABLET, DELAYED RELEASE in 1 POUCH (70518-3431-3) 100 pouch2022-06-280000-00-00NoNoCurrent
70518-3431-3705183431031 in 1 POUCHHistorical
70518-3431-47051834310430 in 1 BLISTER PACKHistorical