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, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

divalproex sodium 500 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3477
Product ID 70518-3477_45369e96-5a20-ffba-e063-6294a90a0bbd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209286
Listing Expiration 2026-12-31
Marketing Start 2022-08-16

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 705183477
Hyphenated Format 70518-3477

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 ANDA209286 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-3477-0)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3477-1)
  • 100 POUCH in 1 BOX (70518-3477-3) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-3477-4)
  • 100 POUCH in 1 BOX (70518-3477-5) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-3477-6)
source: ndc

Packages (4)

70518-3477-0 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-3477-0) 70518-3477-1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3477-1) 70518-3477-3 100 POUCH in 1 BOX (70518-3477-3) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-3477-4) 70518-3477-5 100 POUCH in 1 BOX (70518-3477-5) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-3477-6)

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": "45369e96-5a20-ffba-e063-6294a90a0bbd", "openfda": {"unii": ["644VL95AO6"], "rxcui": ["1099569"], "spl_set_id": ["6af40b06-0a92-454c-9277-80e89de27231"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-3477-0)", "package_ndc": "70518-3477-0", "marketing_start_date": "20220816"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3477-1)", "package_ndc": "70518-3477-1", "marketing_start_date": "20221014"}, {"sample": false, "description": "100 POUCH in 1 BOX (70518-3477-3)  / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-3477-4)", "package_ndc": "70518-3477-3", "marketing_start_date": "20230517"}, {"sample": false, "description": "100 POUCH in 1 BOX (70518-3477-5)  / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-3477-6)", "package_ndc": "70518-3477-5", "marketing_start_date": "20230823"}], "brand_name": "Divalproex sodium", "product_id": "70518-3477_45369e96-5a20-ffba-e063-6294a90a0bbd", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "70518-3477", "generic_name": "Divalproex sodium", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Divalproex sodium", "active_ingredients": [{"name": "DIVALPROEX SODIUM", "strength": "500 mg/1"}], "application_number": "ANDA209286", "marketing_category": "ANDA", "marketing_start_date": "20220816", "listing_expiration_date": "20261231"}