divalproex sodium

Generic: divalproex sodium

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

Drug Facts

Product Profile

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

divalproex sodium 500 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-0473
Product ID 0378-0473_1d6676f1-24a8-44aa-aa49-1a81c0705436
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077567
Listing Expiration 2027-12-31
Marketing Start 2009-02-02

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 03780473
Hyphenated Format 0378-0473

Supplemental Identifiers

RxCUI
1099563 1099569
UPC
0303780473010 0303780472013
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 ANDA077567 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0473-01)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0473-05)
source: ndc

Packages (2)

0378-0473-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0473-01) 0378-0473-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0473-05)

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": "1d6676f1-24a8-44aa-aa49-1a81c0705436", "openfda": {"upc": ["0303780473010", "0303780472013"], "unii": ["644VL95AO6"], "rxcui": ["1099563", "1099569"], "spl_set_id": ["00332c65-edad-a153-9c78-628931daa732"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0473-01)", "package_ndc": "0378-0473-01", "marketing_start_date": "20090202"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0473-05)", "package_ndc": "0378-0473-05", "marketing_start_date": "20090202"}], "brand_name": "Divalproex Sodium", "product_id": "0378-0473_1d6676f1-24a8-44aa-aa49-1a81c0705436", "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": "0378-0473", "generic_name": "divalproex sodium", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Divalproex Sodium", "active_ingredients": [{"name": "DIVALPROEX SODIUM", "strength": "500 mg/1"}], "application_number": "ANDA077567", "marketing_category": "ANDA", "marketing_start_date": "20090202", "listing_expiration_date": "20271231"}