divalproex sodium

Generic: divalproex sodium

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name divalproex sodium
Generic Name divalproex sodium
Labeler coupler llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

divalproex sodium 500 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1631
Product ID 67046-1631_46b2e561-6b18-1a8f-e063-6394a90a67a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214643
Listing Expiration 2026-12-31
Marketing Start 2025-12-24

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 670461631
Hyphenated Format 67046-1631

Supplemental Identifiers

RxCUI
1099569
UNII
644VL95AO6

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 ANDA214643 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (67046-1631-3)
source: ndc

Packages (1)

67046-1631-3 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (67046-1631-3)

Ingredients (1)

divalproex sodium (500 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": "46b2e561-6b18-1a8f-e063-6394a90a67a0", "openfda": {"unii": ["644VL95AO6"], "rxcui": ["1099569"], "spl_set_id": ["46b2e8a9-5d50-d0b2-e063-6294a90a1b47"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (67046-1631-3)", "package_ndc": "67046-1631-3", "marketing_start_date": "20251224"}], "brand_name": "divalproex sodium", "product_id": "67046-1631_46b2e561-6b18-1a8f-e063-6394a90a67a0", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "67046-1631", "generic_name": "divalproex sodium", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "divalproex sodium", "active_ingredients": [{"name": "DIVALPROEX SODIUM", "strength": "500 mg/1"}], "application_number": "ANDA214643", "marketing_category": "ANDA", "marketing_start_date": "20251224", "listing_expiration_date": "20261231"}