FDA.reportPublic FDA data

Divalproex sodium

Product NDC
31722-021
11-digit product format
317220021
Labeler code
31722
Product ID
31722-021_3ceedd19-b7f3-c44c-e063-6294a90afc44
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA215527
Marketing category
ANDA
Marketing start
2023-09-23
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Divalproex sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIVALPROEX SODIUM250 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
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
31722-021-01Divalproex sodium100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1004
31722-021-05Divalproex sodium500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-021-01EA - Each31722-02114710d17-c95f-4bd9-ba51-f5264516e25112024-07-12
31722-021-05EA - Each31722-021dd54acc4-ddcc-45e0-849e-71f7a39a2b8612024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-021DIVALPROEX SODIUM (DIVALPROEX SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]3Current NDC, 2 package rows20250416_e8e954d4-54e3-491c-867c-b3b656b70f23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSNe8e954d4-54e3-491c-867c-b3b656b70f234
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNe8e954d4-54e3-491c-867c-b3b656b70f234
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCDe8e954d4-54e3-491c-867c-b3b656b70f234
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDe8e954d4-54e3-491c-867c-b3b656b70f234
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSYe8e954d4-54e3-491c-867c-b3b656b70f234
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYe8e954d4-54e3-491c-867c-b3b656b70f234

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-021-0131722002101100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-021-01) 2023-09-26NoNoHistorical
31722-021-0531722002105500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-021-05) 2023-09-26NoNoHistorical