divalproex sodium

Generic: divalproex sodium

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name divalproex sodium
Generic Name divalproex sodium
Labeler camber pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

divalproex sodium 500 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-022
Product ID 31722-022_3ceedd19-b7f3-c44c-e063-6294a90afc44
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215527
Listing Expiration 2026-12-31
Marketing Start 2023-09-26

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 31722022
Hyphenated Format 31722-022

Supplemental Identifiers

RxCUI
1099563 1099569
UPC
0331722022057 0331722022019 0331722021012
UNII
644VL95AO6

Packaging Origin

Original Packager
true

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 ANDA215527 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-022-01)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-022-05)
source: ndc

Packages (2)

31722-022-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-022-01) 31722-022-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-022-05)

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": "3ceedd19-b7f3-c44c-e063-6294a90afc44", "openfda": {"upc": ["0331722022057", "0331722022019", "0331722021012"], "unii": ["644VL95AO6"], "rxcui": ["1099563", "1099569"], "spl_set_id": ["e8e954d4-54e3-491c-867c-b3b656b70f23"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-022-01)", "package_ndc": "31722-022-01", "marketing_start_date": "20230926"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-022-05)", "package_ndc": "31722-022-05", "marketing_start_date": "20230926"}], "brand_name": "Divalproex sodium", "product_id": "31722-022_3ceedd19-b7f3-c44c-e063-6294a90afc44", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "31722-022", "generic_name": "Divalproex sodium", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Divalproex sodium", "active_ingredients": [{"name": "DIVALPROEX SODIUM", "strength": "500 mg/1"}], "application_number": "ANDA215527", "marketing_category": "ANDA", "marketing_start_date": "20230926", "listing_expiration_date": "20261231"}