FDA.reportPublic FDA data

DIVALPROEX SODIUM

Product NDC
61919-249
11-digit product format
619190249
Labeler code
61919
Product ID
61919-249_4d3b1fe0-aac6-600d-e063-6394a90a4a87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
DirectRx
Application
ANDA079163
Marketing category
ANDA
Marketing start
2022-04-06
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
57fc3d01-4737-4091-9728-9e8a4c9e708dProduct name120200121
5d67ecc7-47c7-ec5e-e9eb-71bf00250645Product name120140508
97fce1a8-50c4-f088-0e31-64d82b6e9081Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-249-602025-01-30C16284748780-19d75b9d0-4ee8-f424-e053-dadaa90a57ceDIVALPROEX SODIUM
61919-249-302022-04-20C16284748780-19d75b9d0-4ee8-f424-e053-dadaa90a57ceDIVALPROEX SODIUM
61919-249-602022-04-20C16284748780-19d75b9d0-4ee8-f424-e053-dadaa90a57ceDIVALPROEX SODIUM
61919-249-302020-01-31C16284748780-19d75b9d0-4ee8-f424-e053-dadaa90a57ceDIVALPROEX SODIUM
61919-249-602020-01-31C16284748780-19d75b9d0-4ee8-f424-e053-dadaa90a57ceDIVALPROEX SODIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-249-30DIVALPROEX SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE304
61919-249-60DIVALPROEX SODIUM60 in 1 BOTTLETABLET, DELAYED RELEASE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-249-30EA - Each61919-2498492a19f-fff9-46a8-8e8a-10e76316440112016-09-02
61919-249-60EA - Each61919-249503093bc-4800-4ad2-935d-a5dd31cd479812016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]1
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MDIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]1
POLYETHYLENE GLYCOL 3000INACTIVE INGREDIENTSA1B764746DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]1
SHELLACINACTIVE INGREDIENT46N107B71ODIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QODIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJDIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]1
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]1
VANILLININACTIVE INGREDIENTCHI530446XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-249DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]2Current NDC, Legacy NDC, 2 package rows20220421_ce12c7b1-caa9-4224-bb5f-3e20e0281d66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSNce12c7b1-caa9-4224-bb5f-3e20e0281d664
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCDce12c7b1-caa9-4224-bb5f-3e20e0281d664

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-249-306191902493030 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-249-30) 2022-04-06NoNoHistorical
61919-249-606191902496060 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-249-60) 2022-04-060000-00-00NoNoCurrent