Divalproex sodium

Product NDC
72789-286
11-digit product format
727890286
Labeler code
72789
Product ID
72789-286_3caae1a2-be5d-809c-e063-6294a90ad105
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA209286
Marketing category
ANDA
Marketing start
2020-09-18
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Divalproex sodium
Listing expiration
2026-12-31

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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
72789-286-60Divalproex sodium60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE6017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-286DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]16Current NDC, Legacy NDC, 1 package rows20240719_392df14f-4d65-4be9-973b-1f0ce1013d8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSN392df14f-4d65-4be9-973b-1f0ce1013d8f17
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCD392df14f-4d65-4be9-973b-1f0ce1013d8f17
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSY392df14f-4d65-4be9-973b-1f0ce1013d8f17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-286-607278902866060 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-286-60) 2022-11-170000-00-00NoNoCurrent