FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
17856-0798
11-digit product format
178560798
Labeler code
17856
Product ID
17856-0798_23e87b0e-9ede-4fc8-aeb9-67003a2a42b5
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
2018-10-29
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

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
17856-0798-12020-01-31C16284748780-19d75b9d0-e8ab-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DIVALPROEX SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM DELAYED-RELEASE TABLETS. DIVALPROEX SODIUM delayed-release tablets, for oral use Initial U.S. Approval: 1983

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0798-1Divalproex Sodium1 in 1 POUCHTABLET, DELAYED RELEASE11
17856-0798-1Divalproex Sodium100 in 1 CASETABLET, DELAYED RELEASE1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0798DIVALPROEX SODIUM TABLET, DELAYED RELEASE [ATLANTIC BIOLOGICALS CORP.]1Legacy NDC, 2 package rows20181031_3c95fce8-42d7-432a-adeb-1e79f9c3d5f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSN3c95fce8-42d7-432a-adeb-1e79f9c3d5f31
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCD3c95fce8-42d7-432a-adeb-1e79f9c3d5f31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
17856-0798-1178560798011 in 1 POUCHHistorical