FDA.reportPublic FDA data

divalproex sodium

Product NDC
29300-381
11-digit product format
293000381
Labeler code
29300
Product ID
29300-381_5061f4f1-32fe-4ab4-8787-e054053108d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA214643
Marketing category
ANDA
Marketing start
2022-02-25
Substance
DIVALPROEX SODIUM
Active strength
500 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 SODIUM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099563, 1099569

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b10a892b-b985-4cbc-9547-9ac4b72b784fProduct name220250818
7a3a03f1-382a-f9ec-0741-ff24dcbfed69Product name720250624
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
57fc3d01-4737-4091-9728-9e8a4c9e708dProduct name120200121
5d67ecc7-47c7-ec5e-e9eb-71bf00250645Product name120140508
97fce1a8-50c4-f088-0e31-64d82b6e9081Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29300-381-01divalproex sodium100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10013
29300-381-05divalproex sodium500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE50013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-381-01EA - Each29300-38132641a58-c77d-4943-8588-8083897aab8512022-10-06
29300-381-05EA - Each29300-381db4a0ca8-2491-4bfe-ba41-f5b077322c8d12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-381DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]10Current NDC, Legacy NDC, 2 package rows20250227_1d4129ae-0ce8-4a04-9f9d-c770508de8ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSN1d4129ae-0ce8-4a04-9f9d-c770508de8ed13
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN1d4129ae-0ce8-4a04-9f9d-c770508de8ed13
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCD1d4129ae-0ce8-4a04-9f9d-c770508de8ed13
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD1d4129ae-0ce8-4a04-9f9d-c770508de8ed13
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSY1d4129ae-0ce8-4a04-9f9d-c770508de8ed13
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY1d4129ae-0ce8-4a04-9f9d-c770508de8ed13
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN3eee54a6-5b4c-330d-e063-6394a90a9f181
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNd48af379-bd5d-48e1-ad2d-86c493d9cbea1
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNe5fcf5b1-263e-43e0-9424-e613d5cca3fa1
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD3eee54a6-5b4c-330d-e063-6394a90a9f181
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDd48af379-bd5d-48e1-ad2d-86c493d9cbea1
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDe5fcf5b1-263e-43e0-9424-e613d5cca3fa1
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY3eee54a6-5b4c-330d-e063-6394a90a9f181
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYd48af379-bd5d-48e1-ad2d-86c493d9cbea1
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYe5fcf5b1-263e-43e0-9424-e613d5cca3fa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
29300-381-0129300038101100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (29300-381-01) 2022-07-150000-00-00NoNoCurrent
29300-381-0529300038105500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (29300-381-05) 2022-07-150000-00-00NoNoCurrent