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, DELAYED RELEASE
Routes
ORAL
Active Ingredients

divalproex sodium 250 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-402
Product ID 65862-402_c42b86df-c94b-4e25-9ce2-737ea613374f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090554
Listing Expiration 2026-12-31
Marketing Start 2014-10-24

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 65862402
Hyphenated Format 65862-402

Supplemental Identifiers

RxCUI
1099625 1099678 1099870
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 ANDA090554 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-402-01)
  • 500 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-402-05)
  • 10 BLISTER PACK in 1 CARTON (65862-402-10) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • 3000 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-402-39)
  • 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-402-99)
source: ndc

Packages (5)

65862-402-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-402-01) 65862-402-05 500 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-402-05) 65862-402-10 10 BLISTER PACK in 1 CARTON (65862-402-10) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK 65862-402-39 3000 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-402-39) 65862-402-99 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-402-99)

Ingredients (1)

divalproex sodium (250 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": "c42b86df-c94b-4e25-9ce2-737ea613374f", "openfda": {"unii": ["644VL95AO6"], "rxcui": ["1099625", "1099678", "1099870"], "spl_set_id": ["dbd47222-14f1-4588-a009-9b81b55ca60d"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-402-01)", "package_ndc": "65862-402-01", "marketing_start_date": "20141024"}, {"sample": false, "description": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-402-05)", "package_ndc": "65862-402-05", "marketing_start_date": "20141024"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-402-10)  / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "65862-402-10", "marketing_start_date": "20141024"}, {"sample": false, "description": "3000 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-402-39)", "package_ndc": "65862-402-39", "marketing_start_date": "20141024"}, {"sample": false, "description": "1000 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-402-99)", "package_ndc": "65862-402-99", "marketing_start_date": "20141024"}], "brand_name": "Divalproex Sodium", "product_id": "65862-402_c42b86df-c94b-4e25-9ce2-737ea613374f", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "65862-402", "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": "250 mg/1"}], "application_number": "ANDA090554", "marketing_category": "ANDA", "marketing_start_date": "20141024", "listing_expiration_date": "20261231"}