FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
60687-868
11-digit product format
606870868
Labeler code
60687
Product ID
60687-868_3a9c13b7-690a-9438-e063-6394a90ac202
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA079163
Marketing category
ANDA
Marketing start
2025-03-21
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
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 SODIUM250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099625, 1099678, 1099870

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-868-01Divalproex Sodium100 in 1 CARTONTABLET, DELAYED RELEASE1002
60687-868-11Divalproex Sodium1 in 1 BLISTER PACKTABLET, DELAYED RELEASE12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-868-01EA - Each60687-8682200836b-1eca-4aef-975e-d2c92d5e757c12025-03-04
60687-868-11EA - Each60687-8682c4f2b87-7ada-4fb0-a889-1be07f1826b512025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-868DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1Current NDC, 2 package rows20250112_ca6bbec6-5631-4436-957e-fb8707e1683d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099625divalproex sodium 125 MG Delayed Release Oral TabletPSNca6bbec6-5631-4436-957e-fb8707e1683d2
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNca6bbec6-5631-4436-957e-fb8707e1683d2
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSNca6bbec6-5631-4436-957e-fb8707e1683d2
1099625divalproex sodium 125 MG Delayed Release Oral TabletSCDca6bbec6-5631-4436-957e-fb8707e1683d2
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDca6bbec6-5631-4436-957e-fb8707e1683d2
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCDca6bbec6-5631-4436-957e-fb8707e1683d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-868-0160687086801100 BLISTER PACK in 1 CARTON (60687-868-01) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-868-11) 100 blister pack2025-03-21NoNoHistorical
60687-868-11606870868111 in 1 BLISTER PACKHistorical