divalproex sodium

Generic: divalproex sodium

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name divalproex sodium
Generic Name divalproex sodium
Labeler amneal pharmaceuticals llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

divalproex sodium 250 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-755
Product ID 65162-755_eafef6af-5c62-46de-a556-b83d554b2a5f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203730
Listing Expiration 2027-12-31
Marketing Start 2015-06-01

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 65162755
Hyphenated Format 65162-755

Supplemental Identifiers

UPC
0365162755107 0365162757101
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 ANDA203730 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-755-10)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-755-50)
source: ndc

Packages (2)

65162-755-10 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-755-10) 65162-755-50 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-755-50)

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": "eafef6af-5c62-46de-a556-b83d554b2a5f", "openfda": {"upc": ["0365162755107", "0365162757101"], "unii": ["644VL95AO6"], "spl_set_id": ["7d3352ee-a240-43ff-a243-29ad2bc989c7"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-755-10)", "package_ndc": "65162-755-10", "marketing_start_date": "20150601"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-755-50)", "package_ndc": "65162-755-50", "marketing_start_date": "20150601"}], "brand_name": "Divalproex Sodium", "product_id": "65162-755_eafef6af-5c62-46de-a556-b83d554b2a5f", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "65162-755", "generic_name": "Divalproex Sodium", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Divalproex Sodium", "active_ingredients": [{"name": "DIVALPROEX SODIUM", "strength": "250 mg/1"}], "application_number": "ANDA203730", "marketing_category": "ANDA", "marketing_start_date": "20150601", "listing_expiration_date": "20271231"}