FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
70518-1556
11-digit product format
705181556
Labeler code
70518
Product ID
70518-1556_50ace03d-876c-bd82-e063-6394a90a7823
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA203730
Marketing category
ANDA
Marketing start
2018-10-19
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
Rxcui1099563

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b10a892b-b985-4cbc-9547-9ac4b72b784fProduct name220250818
7a3a03f1-382a-f9ec-0741-ff24dcbfed69Product name720250624
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
57fc3d01-4737-4091-9728-9e8a4c9e708dProduct name120200121
5d67ecc7-47c7-ec5e-e9eb-71bf00250645Product name120140508
97fce1a8-50c4-f088-0e31-64d82b6e9081Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1556-0Divalproex Sodium30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE3022
70518-1556-1Divalproex Sodium100 in 1 BOXTABLET, EXTENDED RELEASE10022
70518-1556-2Divalproex Sodium1 in 1 POUCHTABLET, EXTENDED RELEASE122
70518-1556-3Divalproex Sodium100 in 1 BOXTABLET, EXTENDED RELEASE10022
70518-1556-4Divalproex Sodium1 in 1 POUCHTABLET, EXTENDED RELEASE122
70518-1556-5Divalproex Sodium30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE3022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1556DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]18Current NDC, Legacy NDC, 6 package rows20250226_3b41cd15-9981-4d44-9c4b-e84168d86453.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSN3b41cd15-9981-4d44-9c4b-e84168d8645322
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCD3b41cd15-9981-4d44-9c4b-e84168d8645322
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSY3b41cd15-9981-4d44-9c4b-e84168d8645322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1556-07051815560030 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-1556-0) 2018-10-190000-00-00NoNoCurrent
70518-1556-170518155601100 POUCH in 1 BOX (70518-1556-1) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-1556-2) 100 pouch2019-07-100000-00-00NoNoCurrent
70518-1556-2705181556021 in 1 POUCHHistorical
70518-1556-370518155603100 POUCH in 1 BOX (70518-1556-3) > 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-1556-4) 100 pouch2022-11-070000-00-00NoNoCurrent
70518-1556-4705181556041 in 1 POUCHHistorical
70518-1556-57051815560530 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-1556-5) 2024-06-29NoNoCurrent