divalproex sodium

Generic: divalproex sodium

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name divalproex sodium
Generic Name divalproex sodium
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

divalproex sodium 500 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-249
Product ID 71610-249_3cb12547-8039-47da-9899-9ac1efb13a87
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 71610249
Hyphenated Format 71610-249

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 ANDA202419 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-30)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-53)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-60)
  • 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-70)
  • 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-80)
source: ndc

Packages (5)

71610-249-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-30) 71610-249-53 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-53) 71610-249-60 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-60) 71610-249-70 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-70) 71610-249-80 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-80)

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": "3cb12547-8039-47da-9899-9ac1efb13a87", "openfda": {"unii": ["644VL95AO6"], "rxcui": ["1099569"], "spl_set_id": ["41e32cd5-1393-4ef1-81cb-8e3795e30682"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-30)", "package_ndc": "71610-249-30", "marketing_start_date": "20200915"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-53)", "package_ndc": "71610-249-53", "marketing_start_date": "20190314"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-60)", "package_ndc": "71610-249-60", "marketing_start_date": "20190314"}, {"sample": false, "description": "120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-70)", "package_ndc": "71610-249-70", "marketing_start_date": "20190314"}, {"sample": false, "description": "180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-80)", "package_ndc": "71610-249-80", "marketing_start_date": "20201009"}], "brand_name": "Divalproex sodium", "product_id": "71610-249_3cb12547-8039-47da-9899-9ac1efb13a87", "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": "71610-249", "generic_name": "Divalproex sodium", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "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"}