divalproex sodium

Generic: divalproex sodium

Labeler: bionpharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name divalproex sodium
Generic Name divalproex sodium
Labeler bionpharma inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

divalproex sodium 125 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-433
Product ID 69452-433_d5479215-dc0c-4fb3-bbec-01645d675e7c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078853
Listing Expiration 2026-12-31
Marketing Start 2024-06-26

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 69452433
Hyphenated Format 69452-433

Supplemental Identifiers

RxCUI
1099625 1099678 1099870
UPC
0369452435205
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 ANDA078853 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
source: ndc
Packaging
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-433-13)
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-433-20)
  • 500 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-433-30)
source: ndc

Packages (3)

69452-433-13 30 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-433-13) 69452-433-20 100 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-433-20) 69452-433-30 500 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-433-30)

Ingredients (1)

divalproex sodium (125 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": "d5479215-dc0c-4fb3-bbec-01645d675e7c", "openfda": {"upc": ["0369452435205"], "unii": ["644VL95AO6"], "rxcui": ["1099625", "1099678", "1099870"], "spl_set_id": ["19064624-81d1-4ce3-bfe4-955bad6af6a2"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-433-13)", "package_ndc": "69452-433-13", "marketing_start_date": "20240626"}, {"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-433-20)", "package_ndc": "69452-433-20", "marketing_start_date": "20240626"}, {"sample": false, "description": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-433-30)", "package_ndc": "69452-433-30", "marketing_start_date": "20240626"}], "brand_name": "divalproex sodium", "product_id": "69452-433_d5479215-dc0c-4fb3-bbec-01645d675e7c", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "69452-433", "generic_name": "divalproex sodium", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "divalproex sodium", "active_ingredients": [{"name": "DIVALPROEX SODIUM", "strength": "125 mg/1"}], "application_number": "ANDA078853", "marketing_category": "ANDA", "marketing_start_date": "20240626", "listing_expiration_date": "20261231"}