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 70518-3459
Product ID 70518-3459_3c2e3726-c1f1-b29d-e063-6294a90a161b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078182
Marketing Start 2022-07-25
Marketing End 2027-06-23

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 705183459
Hyphenated Format 70518-3459

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 ANDA078182 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 POUCH in 1 BOX (70518-3459-0) / 1 TABLET, DELAYED RELEASE in 1 POUCH (70518-3459-1)
  • 60 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-3459-2)
  • 30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-3459-3)
source: ndc

Packages (3)

70518-3459-0 100 POUCH in 1 BOX (70518-3459-0) / 1 TABLET, DELAYED RELEASE in 1 POUCH (70518-3459-1) 70518-3459-2 60 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-3459-2) 70518-3459-3 30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-3459-3)

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": "3c2e3726-c1f1-b29d-e063-6294a90a161b", "openfda": {"unii": ["644VL95AO6"], "rxcui": ["1099678"], "spl_set_id": ["fb8b7710-6827-4fa2-a0a1-d290f533b16b"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 POUCH in 1 BOX (70518-3459-0)  / 1 TABLET, DELAYED RELEASE in 1 POUCH (70518-3459-1)", "package_ndc": "70518-3459-0", "marketing_end_date": "20270623", "marketing_start_date": "20220725"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-3459-2)", "package_ndc": "70518-3459-2", "marketing_end_date": "20270623", "marketing_start_date": "20230709"}, {"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-3459-3)", "package_ndc": "70518-3459-3", "marketing_end_date": "20270623", "marketing_start_date": "20240926"}], "brand_name": "Divalproex Sodium", "product_id": "70518-3459_3c2e3726-c1f1-b29d-e063-6294a90a161b", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "70518-3459", "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": "ANDA078182", "marketing_category": "ANDA", "marketing_end_date": "20270623", "marketing_start_date": "20220725"}