FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
37662-2864
11-digit product format
376622864
Labeler code
37662
Product ID
37662-2864_f7fec516-ec70-6248-e053-6294a90a3342
Type
HUMAN OTC DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
PELLET
Route
ORAL
Labeler
Hahnemann Laboratories, INC.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-03-28
Substance
VALPROATE SODIUM
Active strength
30 [hp_C]/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
VALPROATE SODIUM30 [hp_C]/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5VOM6GYJ0D

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
37662-2864-1Divalproex Sodium80 in 1 VIAL, GLASSPELLET801
37662-2864-2Divalproex Sodium200 in 1 VIAL, GLASSPELLET2001
37662-2864-3Divalproex Sodium1200 in 1 BOTTLE, GLASSPELLET12001
37662-2864-4Divalproex Sodium4000 in 1 BOTTLE, GLASSPELLET40001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37662-2864DIVALPROEX SODIUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, 4 package rows20230628_f7fec516-ec6f-6248-e053-6294a90a3342.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37662-2864-13766228640180 PELLET in 1 VIAL, GLASS (37662-2864-1) 80 pellet2023-03-28NoNoHistorical
37662-2864-237662286402200 PELLET in 1 VIAL, GLASS (37662-2864-2) 200 pellet2023-03-28NoNoHistorical
37662-2864-3376622864031200 PELLET in 1 BOTTLE, GLASS (37662-2864-3) 1200 pellet2023-03-28NoNoHistorical
37662-2864-4376622864044000 PELLET in 1 BOTTLE, GLASS (37662-2864-4) 4000 pellet2023-03-28NoNoHistorical