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 71610-707
Product ID 71610-707_391af5b8-2992-47ad-80dd-9b5c373f7ce4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077567
Listing Expiration 2026-12-31
Marketing Start 2009-02-02

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 71610707
Hyphenated Format 71610-707

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 ANDA077567 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-707-53)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-707-60)
  • 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-707-70)
  • 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-707-80)
source: ndc

Packages (4)

71610-707-53 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-707-53) 71610-707-60 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-707-60) 71610-707-70 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-707-70) 71610-707-80 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-707-80)

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": "391af5b8-2992-47ad-80dd-9b5c373f7ce4", "openfda": {"unii": ["644VL95AO6"], "rxcui": ["1099569"], "spl_set_id": ["0f5bb45e-836b-48ce-9764-2d50edcb202c"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-707-53)", "package_ndc": "71610-707-53", "marketing_start_date": "20230516"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-707-60)", "package_ndc": "71610-707-60", "marketing_start_date": "20230518"}, {"sample": false, "description": "120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-707-70)", "package_ndc": "71610-707-70", "marketing_start_date": "20230516"}, {"sample": false, "description": "180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-707-80)", "package_ndc": "71610-707-80", "marketing_start_date": "20230516"}], "brand_name": "Divalproex Sodium", "product_id": "71610-707_391af5b8-2992-47ad-80dd-9b5c373f7ce4", "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": "71610-707", "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": "ANDA077567", "marketing_category": "ANDA", "marketing_start_date": "20090202", "listing_expiration_date": "20261231"}