divalproex sodium

Generic: divalproex sodium

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

divalproex sodium 500 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-647
Product ID 68001-647_3ff10d5a-070e-fc82-e063-6394a90a161f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214643
Listing Expiration 2026-12-31
Marketing Start 2025-06-06

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 68001647
Hyphenated Format 68001-647

Supplemental Identifiers

RxCUI
1099563 1099569
UPC
0368001647007 0368001646000
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 ANDA214643 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68001-647-00)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68001-647-03)
source: ndc

Packages (2)

68001-647-00 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68001-647-00) 68001-647-03 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68001-647-03)

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": "3ff10d5a-070e-fc82-e063-6394a90a161f", "openfda": {"upc": ["0368001647007", "0368001646000"], "unii": ["644VL95AO6"], "rxcui": ["1099563", "1099569"], "spl_set_id": ["352b4c3c-e419-4827-9e00-febb0164e0f5"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68001-647-00)", "package_ndc": "68001-647-00", "marketing_start_date": "20250806"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68001-647-03)", "package_ndc": "68001-647-03", "marketing_start_date": "20250806"}], "brand_name": "divalproex sodium", "product_id": "68001-647_3ff10d5a-070e-fc82-e063-6394a90a161f", "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": "68001-647", "generic_name": "divalproex sodium", "labeler_name": "BluePoint Laboratories", "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": "20250606", "listing_expiration_date": "20261231"}