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 250 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-289
Product ID 71610-289_214cf544-a872-5727-e063-6294a90a5843
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 71610289
Hyphenated Format 71610-289

Supplemental Identifiers

RxCUI
1099563
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
  • 250 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-30)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-60)
  • 150 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-75)
  • 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-80)
  • 270 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-92)
source: ndc

Packages (5)

71610-289-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-30) 71610-289-60 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-60) 71610-289-75 150 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-75) 71610-289-80 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-80) 71610-289-92 270 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-92)

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": "214cf544-a872-5727-e063-6294a90a5843", "openfda": {"unii": ["644VL95AO6"], "rxcui": ["1099563"], "spl_set_id": ["9a9f5f24-e421-406f-ac91-d1f964245f54"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-30)", "package_ndc": "71610-289-30", "marketing_start_date": "20190605"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-60)", "package_ndc": "71610-289-60", "marketing_start_date": "20190605"}, {"sample": false, "description": "150 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-75)", "package_ndc": "71610-289-75", "marketing_start_date": "20190605"}, {"sample": false, "description": "180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-80)", "package_ndc": "71610-289-80", "marketing_start_date": "20240903"}, {"sample": false, "description": "270 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-92)", "package_ndc": "71610-289-92", "marketing_start_date": "20240903"}], "brand_name": "Divalproex sodium", "product_id": "71610-289_214cf544-a872-5727-e063-6294a90a5843", "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": "71610-289", "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": "250 mg/1"}], "application_number": "ANDA202419", "marketing_category": "ANDA", "marketing_start_date": "20140602", "listing_expiration_date": "20261231"}