FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
62756-797
11-digit product format
627560797
Labeler code
62756
Product ID
62756-797_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
250 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 SODIUM250 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
62756-797-08Divalproex Sodium100 in 1 BOTTLETABLET, DELAYED RELEASE10034
62756-797-13Divalproex Sodium500 in 1 BOTTLETABLET, DELAYED RELEASE50034
62756-797-18Divalproex Sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE100034
62756-797-83Divalproex Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE3034
62756-797-88Divalproex Sodium100 in 1 BOTTLETABLET, DELAYED RELEASE10034

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-797-13EA - Each62756-7971146462c-8eeb-4f67-a959-721c8809d4b112012-07-24
62756-797-88EA - Each62756-797b90f7704-942b-41ff-9fdc-3e69dc08a03c12012-07-24

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 [TYA PHARMACEUTICALS]4
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QODIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QODIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-797DIVALPROEX 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
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNcd6fe37a-d26d-4ae8-a894-b44878e6bf8e103
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDcd6fe37a-d26d-4ae8-a894-b44878e6bf8e103
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN47412563-ec3e-44fd-9f3f-c00b9b09033a102
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD47412563-ec3e-44fd-9f3f-c00b9b09033a102
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
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN90225548-85a8-4ea7-95d3-e8231c36fe5a32
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD90225548-85a8-4ea7-95d3-e8231c36fe5a32
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNbb94bbb1-07c1-49be-8c2c-f5635c65366d9
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDbb94bbb1-07c1-49be-8c2c-f5635c65366d9
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNfb39a94e-93e6-4afe-a300-f80e8f1e0fa68
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSNfb39a94e-93e6-4afe-a300-f80e8f1e0fa68
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDfb39a94e-93e6-4afe-a300-f80e8f1e0fa68
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCDfb39a94e-93e6-4afe-a300-f80e8f1e0fa68
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN0fddf30c-60f0-4d15-b598-ee414988619c4
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSN0fddf30c-60f0-4d15-b598-ee414988619c4
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD0fddf30c-60f0-4d15-b598-ee414988619c4
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCD0fddf30c-60f0-4d15-b598-ee414988619c4
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN57b71a0b-c2bf-4326-9c26-0f2fe56bf5bc3
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD57b71a0b-c2bf-4326-9c26-0f2fe56bf5bc3
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN0bef10ed-e4b5-95ae-e063-6294a90a86eb2
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNd1d4d790-73d5-4a3b-a786-99f2c98125462
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNc8f72850-92d5-4f64-b9f1-657f72bfa15a2
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD0bef10ed-e4b5-95ae-e063-6294a90a86eb2
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDd1d4d790-73d5-4a3b-a786-99f2c98125462
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDc8f72850-92d5-4f64-b9f1-657f72bfa15a2
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN38f4f2fd-400b-ccc4-e063-6294a90a5f411
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN3aff8f08-d8e8-cd13-e063-6394a90aa00c1
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN51132e43-6fda-4cd4-a818-cfd399264e891
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN59b94f04-42a0-2100-e053-2991aa0ab8f11
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSN59b94f04-42a0-2100-e053-2991aa0ab8f11
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD38f4f2fd-400b-ccc4-e063-6294a90a5f411
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD3aff8f08-d8e8-cd13-e063-6394a90aa00c1
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD51132e43-6fda-4cd4-a818-cfd399264e891
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD59b94f04-42a0-2100-e053-2991aa0ab8f11
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCD59b94f04-42a0-2100-e053-2991aa0ab8f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62756-797-0862756079708100 TABLET, DELAYED RELEASE in 1 BOTTLE (62756-797-08) 2008-07-290000-00-00NoNoCurrent
62756-797-1362756079713500 TABLET, DELAYED RELEASE in 1 BOTTLE (62756-797-13) 2008-07-290000-00-00NoNoCurrent
62756-797-18627560797181000 TABLET, DELAYED RELEASE in 1 BOTTLE (62756-797-18) 2008-07-290000-00-00NoNoCurrent
62756-797-836275607978330 TABLET, DELAYED RELEASE in 1 BOTTLE (62756-797-83) 2008-07-290000-00-00NoNoCurrent
62756-797-8862756079788100 TABLET, DELAYED RELEASE in 1 BOTTLE (62756-797-88) 2008-07-290000-00-00NoNoCurrent