divalproex sodium

Generic: divalproex sodium

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name divalproex sodium
Generic Name divalproex sodium
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

divalproex sodium 500 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-2535
Product ID 71335-2535_41db30e4-4563-57fd-e063-6294a90a4cfe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215527
Listing Expiration 2026-12-31
Marketing Start 2023-09-26

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 713352535
Hyphenated Format 71335-2535

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 ANDA215527 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-1)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-2)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-3)
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-4)
source: ndc

Packages (4)

71335-2535-1 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-1) 71335-2535-2 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-2) 71335-2535-3 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-3) 71335-2535-4 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-4)

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": "41db30e4-4563-57fd-e063-6294a90a4cfe", "openfda": {"unii": ["644VL95AO6"], "rxcui": ["1099569"], "spl_set_id": ["d524db34-99c4-4837-a532-a619f82c21ba"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-1)", "package_ndc": "71335-2535-1", "marketing_start_date": "20241210"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-2)", "package_ndc": "71335-2535-2", "marketing_start_date": "20241210"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-3)", "package_ndc": "71335-2535-3", "marketing_start_date": "20241210"}, {"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-4)", "package_ndc": "71335-2535-4", "marketing_start_date": "20241210"}], "brand_name": "Divalproex sodium", "product_id": "71335-2535_41db30e4-4563-57fd-e063-6294a90a4cfe", "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": "71335-2535", "generic_name": "Divalproex sodium", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Divalproex sodium", "active_ingredients": [{"name": "DIVALPROEX SODIUM", "strength": "500 mg/1"}], "application_number": "ANDA215527", "marketing_category": "ANDA", "marketing_start_date": "20230926", "listing_expiration_date": "20261231"}