divalproex sodium

Generic: divalproex sodium

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name divalproex sodium
Generic Name divalproex sodium
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

divalproex sodium 500 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-595
Product ID 65862-595_11845a6c-59de-469b-adb0-5e00f197ab01
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202419
Listing Expiration 2026-12-31
Marketing Start 2014-06-02

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 65862595
Hyphenated Format 65862-595

Supplemental Identifiers

RxCUI
1099563 1099569
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 ANDA202419 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-595-01)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-595-05)
  • 10 BLISTER PACK in 1 CARTON (65862-595-10) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (3)

65862-595-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-595-01) 65862-595-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-595-05) 65862-595-10 10 BLISTER PACK in 1 CARTON (65862-595-10) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

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": "11845a6c-59de-469b-adb0-5e00f197ab01", "openfda": {"unii": ["644VL95AO6"], "rxcui": ["1099563", "1099569"], "spl_set_id": ["6240cee7-6aa8-425c-ba46-f889a640f0fa"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-595-01)", "package_ndc": "65862-595-01", "marketing_start_date": "20140602"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-595-05)", "package_ndc": "65862-595-05", "marketing_start_date": "20140602"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-595-10)  / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "65862-595-10", "marketing_start_date": "20140602"}], "brand_name": "Divalproex sodium", "product_id": "65862-595_11845a6c-59de-469b-adb0-5e00f197ab01", "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": "65862-595", "generic_name": "Divalproex sodium", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Divalproex sodium", "active_ingredients": [{"name": "DIVALPROEX SODIUM", "strength": "500 mg/1"}], "application_number": "ANDA202419", "marketing_category": "ANDA", "marketing_start_date": "20140602", "listing_expiration_date": "20261231"}