FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
29300-139
11-digit product format
293000139
Labeler code
29300
Product ID
29300-139_8e888ed9-2d55-4e95-ba7b-8b437481c947
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA079163
Marketing category
ANDA
Marketing start
2011-10-01
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
29300-139-01Divalproex Sodium100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE10026
29300-139-05Divalproex Sodium500 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE50026
29300-139-10Divalproex Sodium1000 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE100026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-139-01EA - Each29300-13946f55d7e-1b3a-411c-a93a-7f794b3d753a12012-07-24
29300-139-05EA - Each29300-139af891408-5dd6-451e-b730-d6e661528efc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
ALCOHOLINACTIVE INGREDIENT3K9958V90MDIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BDIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
POLYETHYLENE GLYCOL 3000INACTIVE INGREDIENTSA1B764746DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQDIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
SHELLACINACTIVE INGREDIENT46N107B71ODIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QODIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJDIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
VANILLININACTIVE INGREDIENTCHI530446XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECT RX]2
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECT RX]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MDIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECT RX]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECT RX]2
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BDIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECT RX]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECT RX]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECT RX]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECT RX]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECT RX]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECT RX]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECT RX]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECT RX]2
POLYETHYLENE GLYCOL 3000INACTIVE INGREDIENTSA1B764746DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECT RX]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECT RX]2
SHELLACINACTIVE INGREDIENT46N107B71ODIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECT RX]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QODIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECT RX]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECT RX]2
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJDIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECT RX]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECT RX]2
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECT RX]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECT RX]2
VANILLININACTIVE INGREDIENTCHI530446XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECT RX]2
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BDIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOL 3000INACTIVE INGREDIENTSA1B764746DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQDIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QODIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
VANILLININACTIVE INGREDIENTCHI530446XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-139DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]23Current NDC, Legacy NDC, 3 package rows20250223_1ec1a441-218a-4c80-a0cb-69bcc327f472.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN0fb57229-08ef-44d6-b40a-92b2f96ff795102
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD0fb57229-08ef-44d6-b40a-92b2f96ff795102
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN71296464-0c09-4ff2-beb3-377af77dc4cf100
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN1107f190-bef1-41cb-9393-8479b0a56040100
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD71296464-0c09-4ff2-beb3-377af77dc4cf100
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD1107f190-bef1-41cb-9393-8479b0a56040100
1099625divalproex sodium 125 MG Delayed Release Oral TabletPSN1ec1a441-218a-4c80-a0cb-69bcc327f47226
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN1ec1a441-218a-4c80-a0cb-69bcc327f47226
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSN1ec1a441-218a-4c80-a0cb-69bcc327f47226
1099625divalproex sodium 125 MG Delayed Release Oral TabletSCD1ec1a441-218a-4c80-a0cb-69bcc327f47226
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD1ec1a441-218a-4c80-a0cb-69bcc327f47226
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCD1ec1a441-218a-4c80-a0cb-69bcc327f47226
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN8ecfe765-d743-4308-9cd9-4a7b1a229ea922
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD8ecfe765-d743-4308-9cd9-4a7b1a229ea922
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNd67af03a-5261-4358-8787-2e729267ff7e10
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDd67af03a-5261-4358-8787-2e729267ff7e10
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNab6fa448-7485-6644-e053-2a95a90aa1816
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDab6fa448-7485-6644-e053-2a95a90aa1816
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNabac11e6-7ce1-491c-9ac3-61f3df54c4a45
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSNabac11e6-7ce1-491c-9ac3-61f3df54c4a45
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDabac11e6-7ce1-491c-9ac3-61f3df54c4a45
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCDabac11e6-7ce1-491c-9ac3-61f3df54c4a45
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN3de4f119-ceb6-4e73-9273-4be0451b07692
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD3de4f119-ceb6-4e73-9273-4be0451b07692
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN5a050880-e41a-4d54-e053-2991aa0a6da61
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNe170111a-559b-4052-9794-299bdfbfe1051
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD5a050880-e41a-4d54-e053-2991aa0a6da61
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDe170111a-559b-4052-9794-299bdfbfe1051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
29300-139-0129300013901100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (29300-139-01) 2011-10-010000-00-00NoNoCurrent
29300-139-0529300013905500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (29300-139-05) 2011-10-010000-00-00NoNoCurrent
29300-139-10293000139101000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (29300-139-10) 2011-10-010000-00-00NoNoCurrent