FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
50090-2795
11-digit product format
500902795
Labeler code
50090
Product ID
50090-2795_b94367c0-89df-4303-aa11-7ff68dbc0821
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090554
Marketing category
ANDA
Marketing start
2014-10-24
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
2022-12-31
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
57fc3d01-4737-4091-9728-9e8a4c9e708dProduct name120200121
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5d67ecc7-47c7-ec5e-e9eb-71bf00250645Product name120140508
97fce1a8-50c4-f088-0e31-64d82b6e9081Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2795-02023-01-30C16284748780-19d75b9d0-8272-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
50090-2795-02021-09-21C16284748780-19d75b9d0-8272-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
50090-2795-02020-01-31C16284748780-19d75b9d0-8272-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
50090-2795-0Divalproex Sodium33 in 1 BOX, UNIT-DOSETABLET, DELAYED RELEASE336
50090-2795-0Divalproex Sodium1 in 1 BLISTER PACKTABLET, DELAYED RELEASE16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2795-0EA - Each50090-27955969addb-03b9-4a03-b19b-f86aeef5debf12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2795DIVALPROEX SODIUM TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]6Legacy NDC, 2 package rows20210921_c36f34f0-f700-4178-ac85-46c2f7e1f66c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSNc36f34f0-f700-4178-ac85-46c2f7e1f66c6
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCDc36f34f0-f700-4178-ac85-46c2f7e1f66c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2795-05009027950033 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-2795-0) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK33 blister pack2017-01-190000-00-00NoNoCurrent