FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
70518-3055
11-digit product format
705183055
Labeler code
70518
Product ID
70518-3055_4bb9e9d5-a334-c72c-e063-6394a90a22e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090554
Marketing category
ANDA
Marketing start
2021-03-23
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
Rxcui1099678

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
70518-3055-0Divalproex Sodium30 in 1 BLISTER PACKTABLET, DELAYED RELEASE3015
70518-3055-1Divalproex Sodium100 in 1 BOXTABLET, DELAYED RELEASE10015
70518-3055-2Divalproex Sodium1 in 1 POUCHTABLET, DELAYED RELEASE115
70518-3055-3Divalproex Sodium100 in 1 BOXTABLET, DELAYED RELEASE10015
70518-3055-4Divalproex Sodium1 in 1 POUCHTABLET, DELAYED RELEASE115
70518-3055-5Divalproex Sodium60 in 1 BLISTER PACKTABLET, DELAYED RELEASE6015
70518-3055-6Divalproex Sodium30 in 1 BLISTER PACKTABLET, DELAYED RELEASE3015
70518-3055-7Divalproex Sodium30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3055-0EA - Each70518-3055302b9247-c6e7-4df0-9eb8-41615cfe0c2e12026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3055DIVALPROEX SODIUM TABLET, DELAYED RELEASE [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 8 package rows20250214_5926c3ff-c995-4789-941c-d38aa7db94dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN5926c3ff-c995-4789-941c-d38aa7db94dc15
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD5926c3ff-c995-4789-941c-d38aa7db94dc15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3055-07051830550030 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-3055-0) 2021-03-230000-00-00NoNoCurrent
70518-3055-170518305501100 POUCH in 1 BOX (70518-3055-1) > 1 TABLET, DELAYED RELEASE in 1 POUCH (70518-3055-2) 100 pouch2022-03-160000-00-00NoNoCurrent
70518-3055-2705183055021 in 1 POUCHHistorical
70518-3055-370518305503100 POUCH in 1 BOX (70518-3055-3) / 1 TABLET, DELAYED RELEASE in 1 POUCH (70518-3055-4) 100 pouch2022-08-090000-00-00NoNoCurrent
70518-3055-4705183055041 in 1 POUCHHistorical
70518-3055-57051830550560 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-3055-5) 2023-01-040000-00-00NoNoCurrent
70518-3055-67051830550630 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-3055-6) 2023-05-01NoNoHistorical
70518-3055-77051830550730 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-3055-7) 2025-06-30NoNoHistorical