FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
68001-473
11-digit product format
680010473
Labeler code
68001
Product ID
68001-473_52558612-806d-932f-e063-6394a90a4789
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA079163
Marketing category
ANDA
Marketing start
2021-01-20
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
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
68001-473-00Divalproex Sodium100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE10011
68001-473-03Divalproex Sodium500 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE50011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-473-00EA - Each68001-473fa06eb26-81ac-49eb-8d36-a9cedad0ac0a12021-05-05
68001-473-03EA - Each68001-473f1fe4a7f-a660-46ad-832f-d4f2d8ab588112021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-473DIVALPROEX SODIUM TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]8Current NDC, Legacy NDC, 2 package rows20250326_b95494e2-ee7a-7415-e053-2995a90ae852.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099625divalproex sodium 125 MG Delayed Release Oral TabletPSNb95494e2-ee7a-7415-e053-2995a90ae85211
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNb95494e2-ee7a-7415-e053-2995a90ae85211
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSNb95494e2-ee7a-7415-e053-2995a90ae85211
1099625divalproex sodium 125 MG Delayed Release Oral TabletSCDb95494e2-ee7a-7415-e053-2995a90ae85211
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDb95494e2-ee7a-7415-e053-2995a90ae85211
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCDb95494e2-ee7a-7415-e053-2995a90ae85211
1099625divalproex sodium 125 MG Delayed Release Oral TabletPSNca6bbec6-5631-4436-957e-fb8707e1683d2
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNca6bbec6-5631-4436-957e-fb8707e1683d2
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSNca6bbec6-5631-4436-957e-fb8707e1683d2
1099625divalproex sodium 125 MG Delayed Release Oral TabletSCDca6bbec6-5631-4436-957e-fb8707e1683d2
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDca6bbec6-5631-4436-957e-fb8707e1683d2
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCDca6bbec6-5631-4436-957e-fb8707e1683d2
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN26aa6dea-18ae-ca07-e063-6394a90acf2d1
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD26aa6dea-18ae-ca07-e063-6394a90acf2d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-473-0068001047300100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68001-473-00) 2021-01-200000-00-00NoNoCurrent
68001-473-0368001047303500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68001-473-03) 2021-01-200000-00-00NoNoCurrent