FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
29300-138
11-digit product format
293000138
Labeler code
29300
Product ID
29300-138_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
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
29300-138-01Divalproex Sodium100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE10026
29300-138-05Divalproex Sodium500 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE50026
29300-138-10Divalproex Sodium1000 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE100026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-138-01EA - Each29300-1386b861e62-4fa8-4a39-a0fd-8943913ae91112012-07-24
29300-138-05EA - Each29300-1384af6f12e-1fdd-40b6-8a54-5b63b6c1322f12012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-138DIVALPROEX 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
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
1099625divalproex sodium 125 MG Delayed Release Oral TabletPSNc3af30e3-27ff-4285-8e4a-81856f266b329
1099625divalproex sodium 125 MG Delayed Release Oral TabletSCDc3af30e3-27ff-4285-8e4a-81856f266b329

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
29300-138-0129300013801100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (29300-138-01) 2011-10-010000-00-00NoNoCurrent
29300-138-0529300013805500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (29300-138-05) 2011-10-010000-00-00NoNoCurrent
29300-138-10293000138101000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (29300-138-10) 2011-10-010000-00-00NoNoCurrent