levetiracetam

Generic: levetiracetam

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

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler sciegen pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levetiracetam 250 mg/1

Manufacturer
ScieGen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50228-470
Product ID 50228-470_1ea253c3-3086-2b26-e063-6394a90a312e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215069
Listing Expiration 2026-12-31
Marketing Start 2022-05-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50228470
Hyphenated Format 50228-470

Supplemental Identifiers

RxCUI
311288 311289 311290 387003
UPC
0350228472050 0350228470056 0350228472128 0350228471121 0350228473606 0350228471053 0350228470124
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 ANDA215069 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (50228-470-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (50228-470-10)
  • 120 TABLET, FILM COATED in 1 BOTTLE (50228-470-12)
  • 30 TABLET, FILM COATED in 1 BOTTLE (50228-470-30)
source: ndc

Packages (4)

50228-470-05 500 TABLET, FILM COATED in 1 BOTTLE (50228-470-05) 50228-470-10 1000 TABLET, FILM COATED in 1 BOTTLE (50228-470-10) 50228-470-12 120 TABLET, FILM COATED in 1 BOTTLE (50228-470-12) 50228-470-30 30 TABLET, FILM COATED in 1 BOTTLE (50228-470-30)

Ingredients (1)

levetiracetam (250 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": "1ea253c3-3086-2b26-e063-6394a90a312e", "openfda": {"nui": ["N0000008486"], "upc": ["0350228472050", "0350228470056", "0350228472128", "0350228471121", "0350228473606", "0350228471053", "0350228470124"], "unii": ["44YRR34555"], "rxcui": ["311288", "311289", "311290", "387003"], "spl_set_id": ["1d71212b-ac97-4a61-8192-8e8303540019"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["ScieGen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (50228-470-05)", "package_ndc": "50228-470-05", "marketing_start_date": "20220527"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (50228-470-10)", "package_ndc": "50228-470-10", "marketing_start_date": "20220527"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (50228-470-12)", "package_ndc": "50228-470-12", "marketing_start_date": "20220527"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50228-470-30)", "package_ndc": "50228-470-30", "marketing_start_date": "20220527"}], "brand_name": "Levetiracetam", "product_id": "50228-470_1ea253c3-3086-2b26-e063-6394a90a312e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "50228-470", "generic_name": "Levetiracetam", "labeler_name": "ScieGen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "250 mg/1"}], "application_number": "ANDA215069", "marketing_category": "ANDA", "marketing_start_date": "20220527", "listing_expiration_date": "20261231"}