FDA.reportPublic FDA data

Divalproex sodium

Product NDC
71335-1883
11-digit product format
713351883
Labeler code
71335
Product ID
71335-1883_6dcd8d8d-3860-46c8-a8dd-3003604bc821
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209286
Marketing category
ANDA
Marketing start
2020-09-18
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
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 SODIUM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099569

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
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
71335-1883-1Divalproex sodium60 in 1 BOTTLETABLET, EXTENDED RELEASE60105
71335-1883-2Divalproex sodium30 in 1 BOTTLETABLET, EXTENDED RELEASE30105
71335-1883-3Divalproex sodium90 in 1 BOTTLETABLET, EXTENDED RELEASE90105
71335-1883-4Divalproex sodium100 in 1 BOTTLETABLET, EXTENDED RELEASE100105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1883DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 4 package rows20240726_0822300b-68c0-4e70-b1ba-8eb42cf373f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN0822300b-68c0-4e70-b1ba-8eb42cf373f7105
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD0822300b-68c0-4e70-b1ba-8eb42cf373f7105
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY0822300b-68c0-4e70-b1ba-8eb42cf373f7105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1883-17133518830160 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1883-1) 2024-07-180000-00-00NoNoCurrent
71335-1883-27133518830230 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1883-2) 2021-06-210000-00-00NoNoCurrent
71335-1883-37133518830390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1883-3) 2022-08-180000-00-00NoNoCurrent
71335-1883-471335188304100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1883-4) 2022-08-18NoNoHistorical