FDA.reportPublic FDA data

divalproex sodium

Product NDC
17856-0109
11-digit product format
178560109
Labeler code
17856
Product ID
17856-0109_387b221c-08a3-7861-e063-6294a90a1f4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA078919
Marketing category
ANDA
Marketing start
2019-01-31
Substance
DIVALPROEX SODIUM
Active strength
125 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 SODIUM125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099596

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
17856-0109-12025-03-31C16284748780-1f386c649-d70b-0266-e053-dadaa90a7c1aDIVALPROEX SODIUM DELAYED-RELEASE CAPSULES (SPRINKLE) These highlights do not include all the information needed to use DIVALPROEX SODIUM DELAYED-RELEASE CAPSULES (SPRINKLE) safely and effectively. See full prescribing information for DIVALPROEX SODIUM DELAYED-RELEASE CAPSULES (SPRINKLE). DIVALPROEX SODIUM delayed-release capsules (sprinkle), for oral use Initial U.S. Approval: 1989
17856-0109-12023-01-30C16284748780-1f386c649-d70b-0266-e053-dadaa90a7c1aDIVALPROEX SODIUM DELAYED-RELEASE CAPSULES (SPRINKLE) These highlights do not include all the information needed to use DIVALPROEX SODIUM DELAYED-RELEASE CAPSULES (SPRINKLE) safely and effectively. See full prescribing information for DIVALPROEX SODIUM DELAYED-RELEASE CAPSULES (SPRINKLE). DIVALPROEX SODIUM delayed-release capsules (sprinkle), for oral use Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0109-1divalproex sodium100 in 1 BOXCAPSULE, COATED PELLETS1004
17856-0109-1divalproex sodium1 in 1 POUCHCAPSULE, COATED PELLETS14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0109DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ATLANTIC BIOLOGICALS CORP.]3Current NDC, Legacy NDC, 2 package rows20250402_699a9722-27bd-4e90-819b-d4ecb99466c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099596divalproex sodium 125 MG Delayed Release Oral CapsulePSN699a9722-27bd-4e90-819b-d4ecb99466c84
1099596divalproex sodium 125 MG Delayed Release Oral CapsuleSCD699a9722-27bd-4e90-819b-d4ecb99466c84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0109-117856010901100 POUCH in 1 BOX (17856-0109-1) / 1 CAPSULE, COATED PELLETS in 1 POUCH100 pouch2021-01-280000-00-00NoNoCurrent