FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
37662-2868
11-digit product format
376622868
Labeler code
37662
Product ID
37662-2868_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
1 [hp_M]/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 SODIUM1 [hp_M]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5VOM6GYJ0DInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f7fec516-ec6f-6248-e053-6294a90a3342Available on FDA.report

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
37662-2868-1Divalproex Sodium200 in 1 VIAL, GLASSPELLET2001
37662-2868-2Divalproex Sodium500 in 1 VIAL, GLASSPELLET5001
37662-2868-3Divalproex Sodium3000 in 1 BOTTLE, GLASSPELLET30001
37662-2868-4Divalproex Sodium10000 in 1 BOTTLE, GLASSPELLET100001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37662-2868DIVALPROEX SODIUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, 4 package rows20230628_f7fec516-ec6f-6248-e053-6294a90a3342.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Divalproex SodiumDIVALPROEX SODIUMHahnemann Laboratories, INC.f7fec516-ec6f-6248-e053-6294a90a33422023-03-28Exact identifier
ndc (product): 37662-2868

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37662-2868-137662286801200 PELLET in 1 VIAL, GLASS (37662-2868-1) 200 pellet2023-03-28NoNoCurrent
37662-2868-237662286802500 PELLET in 1 VIAL, GLASS (37662-2868-2) 500 pellet2023-03-28NoNoCurrent
37662-2868-3376622868033000 PELLET in 1 BOTTLE, GLASS (37662-2868-3) 3000 pellet2023-03-28NoNoCurrent
37662-2868-43766228680410000 PELLET in 1 BOTTLE, GLASS (37662-2868-4) 10000 pellet2023-03-28NoNoCurrent