FDA.reportPublic FDA data

divalproex sodium

Product NDC
60687-915
11-digit product format
606870915
Labeler code
60687
Product ID
60687-915_47e2f52f-946b-05e5-e063-6294a90a5a59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA214643
Marketing category
ANDA
Marketing start
2025-12-29
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
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
60687-915-01divalproex sodium100 in 1 CARTONTABLET, FILM COATED, EXTENDED RE1003
60687-915-02divalproex sodium80 in 1 CARTONTABLET, FILM COATED, EXTENDED RE803
60687-915-11divalproex sodium1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE13
60687-915-93divalproex sodium1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-915-01EA - Each60687-91551fecc20-abbb-4150-a6b8-09a6b3923e2e12026-01-08
60687-915-02EA - Each60687-915fb5fdda5-4fa1-480b-bf9c-d47462da383a12026-01-08
60687-915-11EA - Each60687-9150d38c4a2-a342-4efe-88ac-5e1813a0d45e12026-01-08
60687-915-93EA - Each60687-9150c495831-fb85-45b5-b905-af1e9cb0124412026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSNb12b76a0-4b6e-4cd4-9508-10a2c84d8beb3
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNb12b76a0-4b6e-4cd4-9508-10a2c84d8beb3
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCDb12b76a0-4b6e-4cd4-9508-10a2c84d8beb3
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDb12b76a0-4b6e-4cd4-9508-10a2c84d8beb3
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSYb12b76a0-4b6e-4cd4-9508-10a2c84d8beb3
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYb12b76a0-4b6e-4cd4-9508-10a2c84d8beb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-915-0160687091501100 BLISTER PACK in 1 CARTON (60687-915-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (60687-915-11) 100 blister pack2025-12-29NoNoHistorical
60687-915-026068709150280 BLISTER PACK in 1 CARTON (60687-915-02) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (60687-915-93) 80 blister pack2026-01-08NoNoHistorical
60687-915-11606870915111 in 1 BLISTER PACKHistorical
60687-915-93606870915931 in 1 BLISTER PACKHistorical