FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
0832-7122
11-digit product format
008327122
Labeler code
0832
Product ID
0832-7122_45afcbe0-c2e7-008a-e063-6394a90a111e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA078182
Marketing category
ANDA
Marketing start
2014-03-21
Marketing end
2027-10-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Divalproex Sodium

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
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
0832-7122-11Divalproex Sodium100 in 1 BOTTLETABLET, DELAYED RELEASE10018
0832-7122-15Divalproex Sodium500 in 1 BOTTLETABLET, DELAYED RELEASE50018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-7122-11EA - Each0832-7122fbb45eb8-a35e-4f2b-a2a1-1e898dc716dc12014-12-01
0832-7122-15EA - Each0832-712250b1fe8c-df3d-4a4f-bcba-9ae84d6340d712014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Divalproex SodiumACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UPSHER-SMITH LABORATORIES, INC.]3
Valproic AcidACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, DELAYED RELEASE [UPSHER-SMITH LABORATORIES, INC.]3
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOADIVALPROEX SODIUM TABLET, DELAYED RELEASE [UPSHER-SMITH LABORATORIES, INC.]3
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UPSHER-SMITH LABORATORIES, INC.]3
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UPSHER-SMITH LABORATORIES, INC.]3
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type AINACTIVE INGREDIENTNX76LV5T8JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [UPSHER-SMITH LABORATORIES, INC.]3
povidonesINACTIVE INGREDIENTFZ989GH94EDIVALPROEX SODIUM TABLET, DELAYED RELEASE [UPSHER-SMITH LABORATORIES, INC.]3
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UPSHER-SMITH LABORATORIES, INC.]3
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QODIVALPROEX SODIUM TABLET, DELAYED RELEASE [UPSHER-SMITH LABORATORIES, INC.]3
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [UPSHER-SMITH LABORATORIES, INC.]3
starch, cornINACTIVE INGREDIENTO8232NY3SJDIVALPROEX SODIUM TABLET, DELAYED RELEASE [UPSHER-SMITH LABORATORIES, INC.]3
talcINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [UPSHER-SMITH LABORATORIES, INC.]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, DELAYED RELEASE [UPSHER-SMITH LABORATORIES, INC.]3
triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM TABLET, DELAYED RELEASE [UPSHER-SMITH LABORATORIES, INC.]3
vanillinINACTIVE INGREDIENTCHI530446XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [UPSHER-SMITH LABORATORIES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-7122DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UPSHER-SMITH LABORATORIES, LLC]16Current NDC, Legacy NDC, 2 package rows20240726_02304a23-4a5f-47bc-9687-4044b43f7a20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099625divalproex sodium 125 MG Delayed Release Oral TabletPSN02304a23-4a5f-47bc-9687-4044b43f7a2018
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN02304a23-4a5f-47bc-9687-4044b43f7a2018
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSN02304a23-4a5f-47bc-9687-4044b43f7a2018
1099625divalproex sodium 125 MG Delayed Release Oral TabletSCD02304a23-4a5f-47bc-9687-4044b43f7a2018
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD02304a23-4a5f-47bc-9687-4044b43f7a2018
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCD02304a23-4a5f-47bc-9687-4044b43f7a2018

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0832-7122-1100832712211100 TABLET, DELAYED RELEASE in 1 BOTTLE (0832-7122-11) 2014-03-212027-10-31NoNoCurrent
0832-7122-1500832712215500 TABLET, DELAYED RELEASE in 1 BOTTLE (0832-7122-15) 2014-03-212026-07-31NoNoCurrent