FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
62756-796
11-digit product format
627560796
Labeler code
62756
Product ID
62756-796_9fa8a32e-7def-4ae6-b537-15450ef34bc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA078597
Marketing category
ANDA
Marketing start
2008-07-29
Substance
DIVALPROEX SODIUM
Active strength
125 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 SODIUM125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099625, 1099678, 1099870

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62756-796-08Divalproex Sodium100 in 1 BOTTLETABLET, DELAYED RELEASE10034
62756-796-13Divalproex Sodium500 in 1 BOTTLETABLET, DELAYED RELEASE50034
62756-796-18Divalproex Sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE100034
62756-796-83Divalproex Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE3034
62756-796-88Divalproex Sodium100 in 1 BOTTLETABLET, DELAYED RELEASE10034

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-796-13EA - Each62756-7962f8a51f9-d604-4a3a-85c4-2cd9c7e4239912012-07-24
62756-796-88EA - Each62756-7965b43efac-a24e-4b2b-9811-2b8334b0717e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
AMMONIAINACTIVE INGREDIENT5138Q19F1XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BDIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
POVIDONEINACTIVE INGREDIENTFZ989GH94EDIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
SHELLACINACTIVE INGREDIENT46N107B71ODIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QODIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIVALPROEX SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QODIVALPROEX SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-796DIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]31Current NDC, Legacy NDC, 5 package rows20250226_64797788-fdcb-4d12-a1a4-743ad71bd17b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099625divalproex sodium 125 MG Delayed Release Oral TabletPSN64797788-fdcb-4d12-a1a4-743ad71bd17b34
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN64797788-fdcb-4d12-a1a4-743ad71bd17b34
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSN64797788-fdcb-4d12-a1a4-743ad71bd17b34
1099625divalproex sodium 125 MG Delayed Release Oral TabletSCD64797788-fdcb-4d12-a1a4-743ad71bd17b34
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD64797788-fdcb-4d12-a1a4-743ad71bd17b34
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCD64797788-fdcb-4d12-a1a4-743ad71bd17b34
1099625divalproex sodium 125 MG Delayed Release Oral TabletPSN79132bea-04d8-4dd9-bd31-07f0ba805c2111
1099625divalproex sodium 125 MG Delayed Release Oral TabletSCD79132bea-04d8-4dd9-bd31-07f0ba805c2111
1099625divalproex sodium 125 MG Delayed Release Oral TabletPSNba88eafe-b773-4c41-aa80-be86e799cc864
1099625divalproex sodium 125 MG Delayed Release Oral TabletSCDba88eafe-b773-4c41-aa80-be86e799cc864

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62756-796-0862756079608100 TABLET, DELAYED RELEASE in 1 BOTTLE (62756-796-08) 2008-07-290000-00-00NoNoCurrent
62756-796-1362756079613500 TABLET, DELAYED RELEASE in 1 BOTTLE (62756-796-13) 2008-07-290000-00-00NoNoCurrent
62756-796-18627560796181000 TABLET, DELAYED RELEASE in 1 BOTTLE (62756-796-18) 2008-07-290000-00-00NoNoCurrent
62756-796-836275607968330 TABLET, DELAYED RELEASE in 1 BOTTLE (62756-796-83) 2008-07-290000-00-00NoNoCurrent
62756-796-8862756079688100 TABLET, DELAYED RELEASE in 1 BOTTLE (62756-796-88) 2008-07-290000-00-00NoNoCurrent