levetiracetam

Generic: levetiracetam

Labeler: solco healthcare u.s., llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler solco healthcare u.s., llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

levetiracetam 750 mg/1

Manufacturer
Solco healthcare U.S., LLC

Identifiers & Regulatory

Product NDC 43547-346
Product ID 43547-346_801f853c-1f42-4d65-ae2d-2bace0d5f3f8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203468
Listing Expiration 2026-12-31
Marketing Start 2014-05-01

Pharmacologic Class

Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43547346
Hyphenated Format 43547-346

Supplemental Identifiers

RxCUI
807832 846378
UPC
0343547346065 0343547345068
UNII
44YRR34555
NUI
N0000008486

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 levetiracetam (source: ndc)
Generic Name levetiracetam (source: ndc)
Application Number ANDA203468 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43547-346-06)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43547-346-50)
source: ndc

Packages (2)

43547-346-06 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43547-346-06) 43547-346-50 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43547-346-50)

Ingredients (1)

levetiracetam (750 mg/1)

Linked Drug Pages (1)

LEVETIRACETAM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "801f853c-1f42-4d65-ae2d-2bace0d5f3f8", "openfda": {"nui": ["N0000008486"], "upc": ["0343547346065", "0343547345068"], "unii": ["44YRR34555"], "rxcui": ["807832", "846378"], "spl_set_id": ["bc8644ed-3320-47b5-adf3-8b972bea8abd"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Solco healthcare U.S., LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43547-346-06)", "package_ndc": "43547-346-06", "marketing_start_date": "20140501"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43547-346-50)", "package_ndc": "43547-346-50", "marketing_start_date": "20140501"}], "brand_name": "LEVETIRACETAM", "product_id": "43547-346_801f853c-1f42-4d65-ae2d-2bace0d5f3f8", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "43547-346", "generic_name": "LEVETIRACETAM", "labeler_name": "Solco healthcare U.S., LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVETIRACETAM", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "750 mg/1"}], "application_number": "ANDA203468", "marketing_category": "ANDA", "marketing_start_date": "20140501", "listing_expiration_date": "20261231"}