FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
17856-0797
11-digit product format
178560797
Labeler code
17856
Product ID
17856-0797_3852f152-7d42-e53d-e063-6394a90aef95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA078597
Marketing category
ANDA
Marketing start
2008-07-29
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
Rxcui1099678

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b10a892b-b985-4cbc-9547-9ac4b72b784fProduct name220250818
7a3a03f1-382a-f9ec-0741-ff24dcbfed69Product name720250624
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
57fc3d01-4737-4091-9728-9e8a4c9e708dProduct name120200121
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5d67ecc7-47c7-ec5e-e9eb-71bf00250645Product name120140508
97fce1a8-50c4-f088-0e31-64d82b6e9081Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0797-12025-04-02C16284748780-19d75b9d0-750d-f424-e053-dadaa90a57ceDIVALPROEX SODIUM delayed-release tablets, for oral use Initial U.S. Approval: 1983
17856-0797-12020-01-31C16284748780-19d75b9d0-750d-f424-e053-dadaa90a57ceDIVALPROEX SODIUM delayed-release tablets, for oral use Initial U.S. Approval: 1983

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0797-1Divalproex Sodium1 in 1 POUCHTABLET, DELAYED RELEASE13
17856-0797-1Divalproex Sodium100 in 1 BOX, UNIT-DOSETABLET, DELAYED RELEASE1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0797DIVALPROEX SODIUM TABLET, DELAYED RELEASE [ATLANTIC BIOLOGICALS CORP.]2Current NDC, Legacy NDC, 2 package rows20250406_57b71a0b-c2bf-4326-9c26-0f2fe56bf5bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN57b71a0b-c2bf-4326-9c26-0f2fe56bf5bc3
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD57b71a0b-c2bf-4326-9c26-0f2fe56bf5bc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17856-0797-117856079701100 POUCH in 1 BOX, UNIT-DOSE (17856-0797-1) / 1 TABLET, DELAYED RELEASE in 1 POUCH100 pouch2018-11-02NoNoCurrent