FDA.reportPublic FDA data

Divalproex sodium

Product NDC
68788-8085
11-digit product format
687888085
Labeler code
68788
Product ID
68788-8085_51c1d8be-2013-42d7-909c-b00d32cf29f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA209286
Marketing category
ANDA
Marketing start
2021-10-05
Marketing end
0000-00-00
Substance
DIVALPROEX SODIUM
Active strength
500 1/1
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
68788-8085-32023-01-30C16284748780-1f386c64a-2d54-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000
68788-8085-62023-01-30C16284748780-1f386c64a-2d54-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000
68788-8085-92023-01-30C16284748780-1f386c64a-2d54-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8085-3Divalproex sodium30 in 1 BOTTLETABLET, EXTENDED RELEASE301
68788-8085-6Divalproex sodium60 in 1 BOTTLETABLET, EXTENDED RELEASE601
68788-8085-9Divalproex sodium90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8085-3EA - Each68788-80852030a5d5-3d4f-424c-8305-66db9eba4e7a12021-11-09
68788-8085-6EA - Each68788-8085d43c1743-d0f0-43ce-8425-be97435520a912021-11-09
68788-8085-9EA - Each68788-80855f49a03b-273f-43a0-8eec-e68efeb1ba8612021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8085DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]1Legacy NDC, 3 package rows20211006_51c1d8be-2013-42d7-909c-b00d32cf29f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN51c1d8be-2013-42d7-909c-b00d32cf29f31
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD51c1d8be-2013-42d7-909c-b00d32cf29f31
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY51c1d8be-2013-42d7-909c-b00d32cf29f31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8085-36878880850330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8085-3) 2021-10-050000-00-00NoNoCurrent
68788-8085-66878880850660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8085-6) 2021-10-050000-00-00NoNoCurrent
68788-8085-96878880850990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8085-9) 2021-10-050000-00-00NoNoCurrent