FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
70518-2036
11-digit product format
705182036
Labeler code
70518
Product ID
70518-2036_499b72b7-b905-4be2-e063-6394a90ae98d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA203730
Marketing category
ANDA
Marketing start
2019-04-24
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
Rxcui1099569

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b10a892b-b985-4cbc-9547-9ac4b72b784fProduct name220250818
7a3a03f1-382a-f9ec-0741-ff24dcbfed69Product name720250624
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
57fc3d01-4737-4091-9728-9e8a4c9e708dProduct name120200121
5d67ecc7-47c7-ec5e-e9eb-71bf00250645Product name120140508
97fce1a8-50c4-f088-0e31-64d82b6e9081Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2036-0Divalproex Sodium100 in 1 BOXTABLET, EXTENDED RELEASE10013
70518-2036-1Divalproex Sodium1 in 1 POUCHTABLET, EXTENDED RELEASE113
70518-2036-2Divalproex Sodium30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2036-0EA - Each70518-2036a5901cd5-680e-405d-aae7-34bb3b3ac6db12026-01-08
70518-2036-1EA - Each70518-2036d6c22735-f24e-4192-9860-2492263756d012026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN33f07aac-4dc5-4f97-976a-a84f93497bc613
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD33f07aac-4dc5-4f97-976a-a84f93497bc613
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY33f07aac-4dc5-4f97-976a-a84f93497bc613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2036-070518203600100 POUCH in 1 BOX (70518-2036-0) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-2036-1) 100 pouch2019-04-240000-00-00NoNoCurrent
70518-2036-1705182036011 in 1 POUCHHistorical
70518-2036-27051820360230 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-2036-2) 2020-01-040000-00-00NoNoCurrent