divalproex sodium

Generic: divalproex sodium

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

Drug Facts

Product Profile

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

divalproex sodium 250 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3431
Product ID 70518-3431_409402a6-461c-044b-e063-6294a90ac7da
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078597
Listing Expiration 2026-12-31
Marketing Start 2022-06-03

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 705183431
Hyphenated Format 70518-3431

Supplemental Identifiers

RxCUI
1099678
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 ANDA078597 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 60 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-3431-0)
  • 100 POUCH in 1 BOX (70518-3431-2) / 1 TABLET, DELAYED RELEASE in 1 POUCH (70518-3431-3)
source: ndc

Packages (2)

70518-3431-0 60 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-3431-0) 70518-3431-2 100 POUCH in 1 BOX (70518-3431-2) / 1 TABLET, DELAYED RELEASE in 1 POUCH (70518-3431-3)

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": "409402a6-461c-044b-e063-6294a90ac7da", "openfda": {"unii": ["644VL95AO6"], "rxcui": ["1099678"], "spl_set_id": ["bb94bbb1-07c1-49be-8c2c-f5635c65366d"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-3431-0)", "package_ndc": "70518-3431-0", "marketing_start_date": "20220603"}, {"sample": false, "description": "100 POUCH in 1 BOX (70518-3431-2)  / 1 TABLET, DELAYED RELEASE in 1 POUCH (70518-3431-3)", "package_ndc": "70518-3431-2", "marketing_start_date": "20220628"}], "brand_name": "Divalproex Sodium", "product_id": "70518-3431_409402a6-461c-044b-e063-6294a90ac7da", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "70518-3431", "generic_name": "Divalproex Sodium", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Divalproex Sodium", "active_ingredients": [{"name": "DIVALPROEX SODIUM", "strength": "250 mg/1"}], "application_number": "ANDA078597", "marketing_category": "ANDA", "marketing_start_date": "20220603", "listing_expiration_date": "20261231"}