FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
65162-757
11-digit product format
651620757
Labeler code
65162
Product ID
65162-757_eafef6af-5c62-46de-a556-b83d554b2a5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA203730
Marketing category
ANDA
Marketing start
2015-06-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Divalproex Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIVALPROEX SODIUM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099563, 1099569

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b10a892b-b985-4cbc-9547-9ac4b72b784fProduct name220250818
7a3a03f1-382a-f9ec-0741-ff24dcbfed69Product name720250624
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
57fc3d01-4737-4091-9728-9e8a4c9e708dProduct name120200121
5d67ecc7-47c7-ec5e-e9eb-71bf00250645Product name120140508
97fce1a8-50c4-f088-0e31-64d82b6e9081Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-757-10Divalproex Sodium100 in 1 BOTTLETABLET, EXTENDED RELEASE10023
65162-757-50Divalproex Sodium500 in 1 BOTTLETABLET, EXTENDED RELEASE50023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-757-10EA - Each65162-757299b4757-21e7-42b8-97ae-7c64d86f60c112015-08-04
65162-757-50EA - Each65162-75758f9ca0f-0468-4248-ae68-417864480ff712015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
AMMONIAINACTIVE INGREDIENT5138Q19F1XDIVALPROEX SODIUM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
ETHYL ACRYLATEINACTIVE INGREDIENT71E6178C9TDIVALPROEX SODIUM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIVALPROEX SODIUM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADIVALPROEX SODIUM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
SHELLACINACTIVE INGREDIENT46N107B71ODIVALPROEX SODIUM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-757DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]20Current NDC, Legacy NDC, 2 package rows20250417_7d3352ee-a240-43ff-a243-29ad2bc989c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSN7d3352ee-a240-43ff-a243-29ad2bc989c723
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN7d3352ee-a240-43ff-a243-29ad2bc989c723
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCD7d3352ee-a240-43ff-a243-29ad2bc989c723
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD7d3352ee-a240-43ff-a243-29ad2bc989c723
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSY7d3352ee-a240-43ff-a243-29ad2bc989c723
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY7d3352ee-a240-43ff-a243-29ad2bc989c723
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN33f07aac-4dc5-4f97-976a-a84f93497bc613
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD33f07aac-4dc5-4f97-976a-a84f93497bc613
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY33f07aac-4dc5-4f97-976a-a84f93497bc613
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSNef472176-7f98-4f88-be5e-a101fecb46fd8
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNef472176-7f98-4f88-be5e-a101fecb46fd8
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCDef472176-7f98-4f88-be5e-a101fecb46fd8
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDef472176-7f98-4f88-be5e-a101fecb46fd8
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSYef472176-7f98-4f88-be5e-a101fecb46fd8
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYef472176-7f98-4f88-be5e-a101fecb46fd8
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSNe8cc336b-5191-7f8b-e053-2a95a90a6acb3
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNe8cc336b-5191-7f8b-e053-2a95a90a6acb3
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCDe8cc336b-5191-7f8b-e053-2a95a90a6acb3
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDe8cc336b-5191-7f8b-e053-2a95a90a6acb3
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSYe8cc336b-5191-7f8b-e053-2a95a90a6acb3
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYe8cc336b-5191-7f8b-e053-2a95a90a6acb3
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN59b80d0d-6a53-440a-e053-2991aa0ae8e31
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNfe30c8da-0ae4-48d0-9c0f-9b9d0d7269041
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD59b80d0d-6a53-440a-e053-2991aa0ae8e31
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDfe30c8da-0ae4-48d0-9c0f-9b9d0d7269041
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY59b80d0d-6a53-440a-e053-2991aa0ae8e31
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYfe30c8da-0ae4-48d0-9c0f-9b9d0d7269041

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-757-1065162075710100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-757-10) 2015-06-010000-00-00NoNoCurrent
65162-757-5065162075750500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-757-50) 2015-06-010000-00-00NoNoCurrent