divalproex sodium

Generic: divalproex sodium

Labeler: first nation group, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name divalproex sodium
Generic Name divalproex sodium
Labeler first nation group, llc
Dosage Form CAPSULE, COATED PELLETS
Routes
ORAL
Active Ingredients

divalproex sodium 125 mg/1

Manufacturer
First Nation Group, LLC

Identifiers & Regulatory

Product NDC 81469-492
Product ID 81469-492_04436591-edfc-44f9-9813-cf04136c727a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217358
Listing Expiration 2026-12-31
Marketing Start 2025-11-10

Pharmacologic Class

Classes
anti-epileptic agent [epc] decreased central nervous system disorganized electrical activity [pe] mood stabilizer [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81469492
Hyphenated Format 81469-492

Supplemental Identifiers

RxCUI
1099596
UNII
644VL95AO6

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name divalproex sodium (source: ndc)
Generic Name divalproex sodium (source: ndc)
Application Number ANDA217358 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
source: ndc
Packaging
  • 100 CAPSULE, COATED PELLETS in 1 BOTTLE (81469-492-01)
  • 1000 CAPSULE, COATED PELLETS in 1 BOTTLE (81469-492-10)
source: ndc

Packages (2)

81469-492-01 100 CAPSULE, COATED PELLETS in 1 BOTTLE (81469-492-01) 81469-492-10 1000 CAPSULE, COATED PELLETS in 1 BOTTLE (81469-492-10)

Ingredients (1)

divalproex sodium (125 mg/1)

Linked Drug Pages (1)

divalproex sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "04436591-edfc-44f9-9813-cf04136c727a", "openfda": {"unii": ["644VL95AO6"], "rxcui": ["1099596"], "spl_set_id": ["a76f9909-28c9-4eb7-8ffd-ff6222fea079"], "manufacturer_name": ["First Nation Group, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, COATED PELLETS in 1 BOTTLE (81469-492-01)", "package_ndc": "81469-492-01", "marketing_start_date": "20251110"}, {"sample": false, "description": "1000 CAPSULE, COATED PELLETS in 1 BOTTLE (81469-492-10)", "package_ndc": "81469-492-10", "marketing_start_date": "20251110"}], "brand_name": "divalproex sodium", "product_id": "81469-492_04436591-edfc-44f9-9813-cf04136c727a", "dosage_form": "CAPSULE, COATED PELLETS", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "81469-492", "generic_name": "divalproex sodium", "labeler_name": "First Nation Group, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "divalproex sodium", "active_ingredients": [{"name": "DIVALPROEX SODIUM", "strength": "125 mg/1"}], "application_number": "ANDA217358", "marketing_category": "ANDA", "marketing_start_date": "20251110", "listing_expiration_date": "20261231"}