FDA.reportPublic FDA data

Divalproex sodium

Product NDC
70518-3183
11-digit product format
705183183
Labeler code
70518
Product ID
70518-3183_4ecca60a-adc3-3b17-e063-6294a90ae417
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA209286
Marketing category
ANDA
Marketing start
2021-08-06
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
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
70518-3183-0Divalproex sodium30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE307
70518-3183-1Divalproex sodium100 in 1 BOXTABLET, EXTENDED RELEASE1007
70518-3183-2Divalproex sodium1 in 1 POUCHTABLET, EXTENDED RELEASE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3183-0EA - Each70518-31831f21dba6-a14b-49a4-9bd7-26a5922614b912026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3183DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 3 package rows20241116_aa386ae3-ceac-4e3b-8fb1-ced3107a4c54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSNaa386ae3-ceac-4e3b-8fb1-ced3107a4c547
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCDaa386ae3-ceac-4e3b-8fb1-ced3107a4c547
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSYaa386ae3-ceac-4e3b-8fb1-ced3107a4c547

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3183-07051831830030 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-3183-0) 2021-08-060000-00-00NoNoCurrent
70518-3183-170518318301100 POUCH in 1 BOX (70518-3183-1) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-3183-2) 100 pouch2023-07-30NoNoCurrent
70518-3183-2705183183021 in 1 POUCHHistorical