divalproex sodium

Generic: divalproex sodium

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name divalproex sodium
Generic Name divalproex sodium
Labeler coupler llc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

divalproex sodium 500 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1647
Product ID 67046-1647_4834727a-982f-9ba7-e063-6394a90a8180
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078853
Listing Expiration 2027-12-31
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 670461647
Hyphenated Format 67046-1647

Supplemental Identifiers

RxCUI
1099870
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 ANDA078853 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-1647-3)
source: ndc

Packages (1)

67046-1647-3 30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-1647-3)

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": "4834727a-982f-9ba7-e063-6394a90a8180", "openfda": {"unii": ["644VL95AO6"], "rxcui": ["1099870"], "spl_set_id": ["4834732f-6044-946c-e063-6394a90a5da3"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-1647-3)", "package_ndc": "67046-1647-3", "marketing_start_date": "20240626"}], "brand_name": "divalproex sodium", "product_id": "67046-1647_4834727a-982f-9ba7-e063-6394a90a8180", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "67046-1647", "generic_name": "divalproex sodium", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "divalproex sodium", "active_ingredients": [{"name": "DIVALPROEX SODIUM", "strength": "500 mg/1"}], "application_number": "ANDA078853", "marketing_category": "ANDA", "marketing_start_date": "20240626", "listing_expiration_date": "20271231"}