levetiracetam

Generic: levetiracetam

Labeler: solco healthcare us, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler solco healthcare us, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levetiracetam 500 mg/1

Manufacturer
Solco Healthcare US, LLC

Identifiers & Regulatory

Product NDC 43547-881
Product ID 43547-881_57f09129-7151-4a75-9d73-9dd32f74ba43
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078106
Listing Expiration 2026-12-31
Marketing Start 2012-09-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43547881
Hyphenated Format 43547-881

Supplemental Identifiers

RxCUI
311288 311289 311290 387003
UPC
0343547882150 0343547881153 0343547883065 0343547880156
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 ANDA078106 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE (43547-881-15)
  • 500 TABLET, FILM COATED in 1 BOTTLE (43547-881-50)
source: ndc

Packages (2)

43547-881-15 120 TABLET, FILM COATED in 1 BOTTLE (43547-881-15) 43547-881-50 500 TABLET, FILM COATED in 1 BOTTLE (43547-881-50)

Ingredients (1)

levetiracetam (500 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": "57f09129-7151-4a75-9d73-9dd32f74ba43", "openfda": {"nui": ["N0000008486"], "upc": ["0343547882150", "0343547881153", "0343547883065", "0343547880156"], "unii": ["44YRR34555"], "rxcui": ["311288", "311289", "311290", "387003"], "spl_set_id": ["57f09129-7151-4a75-9d73-9dd32f74ba43"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Solco Healthcare US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (43547-881-15)", "package_ndc": "43547-881-15", "marketing_start_date": "20240901"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (43547-881-50)", "package_ndc": "43547-881-50", "marketing_start_date": "20240901"}], "brand_name": "Levetiracetam", "product_id": "43547-881_57f09129-7151-4a75-9d73-9dd32f74ba43", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "43547-881", "generic_name": "Levetiracetam", "labeler_name": "Solco Healthcare US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "500 mg/1"}], "application_number": "ANDA078106", "marketing_category": "ANDA", "marketing_start_date": "20120911", "listing_expiration_date": "20261231"}