divalproex sodium

Generic: divalproex sodium

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name divalproex sodium
Generic Name divalproex sodium
Labeler avpak
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

divalproex sodium 250 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-259
Product ID 50268-259_47e34870-0259-c99d-e063-6394a90ae59a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203730
Listing Expiration 2027-12-31
Marketing Start 2022-09-16

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 50268259
Hyphenated Format 50268-259

Supplemental Identifiers

RxCUI
1099563 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 ANDA203730 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-259-15) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-259-11)
source: ndc

Packages (1)

50268-259-15 50 BLISTER PACK in 1 BOX (50268-259-15) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-259-11)

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": "47e34870-0259-c99d-e063-6394a90ae59a", "openfda": {"unii": ["644VL95AO6"], "rxcui": ["1099563", "1099569"], "spl_set_id": ["e8cc336b-5191-7f8b-e053-2a95a90a6acb"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-259-15)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-259-11)", "package_ndc": "50268-259-15", "marketing_start_date": "20220916"}], "brand_name": "Divalproex Sodium", "product_id": "50268-259_47e34870-0259-c99d-e063-6394a90ae59a", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "50268-259", "generic_name": "Divalproex Sodium", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Divalproex Sodium", "active_ingredients": [{"name": "DIVALPROEX SODIUM", "strength": "250 mg/1"}], "application_number": "ANDA203730", "marketing_category": "ANDA", "marketing_start_date": "20220916", "listing_expiration_date": "20271231"}