levetiracetam extended-release

Generic: levetiracetam

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

Drug Facts

Product Profile

Brand Name levetiracetam extended-release
Generic Name levetiracetam
Labeler sciegen pharmaceuticals, inc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

levetiracetam 500 mg/1

Manufacturer
ScieGen Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 50228-189
Product ID 50228-189_1d0dd4a0-35e6-418b-e063-6394a90a8b2b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205130
Listing Expiration 2026-12-31
Marketing Start 2020-11-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50228189
Hyphenated Format 50228-189

Supplemental Identifiers

RxCUI
807832 846378
UPC
0350228190602 0350228189606
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 extended-release (source: ndc)
Generic Name levetiracetam (source: ndc)
Application Number ANDA205130 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-189-05)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-189-30)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-189-60)
source: ndc

Packages (3)

50228-189-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-189-05) 50228-189-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-189-30) 50228-189-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-189-60)

Ingredients (1)

levetiracetam (500 mg/1)

Linked Drug Pages (1)

Levetiracetam Extended-Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1d0dd4a0-35e6-418b-e063-6394a90a8b2b", "openfda": {"nui": ["N0000008486"], "upc": ["0350228190602", "0350228189606"], "unii": ["44YRR34555"], "rxcui": ["807832", "846378"], "spl_set_id": ["3e32f341-9926-47a3-a942-d8b9bfa7a55b"], "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, EXTENDED RELEASE in 1 BOTTLE (50228-189-05)", "package_ndc": "50228-189-05", "marketing_start_date": "20201127"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-189-30)", "package_ndc": "50228-189-30", "marketing_start_date": "20201127"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-189-60)", "package_ndc": "50228-189-60", "marketing_start_date": "20201127"}], "brand_name": "Levetiracetam Extended-Release", "product_id": "50228-189_1d0dd4a0-35e6-418b-e063-6394a90a8b2b", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "50228-189", "generic_name": "levetiracetam", "labeler_name": "ScieGen Pharmaceuticals, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "brand_name_suffix": "Extended-Release", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "500 mg/1"}], "application_number": "ANDA205130", "marketing_category": "ANDA", "marketing_start_date": "20201127", "listing_expiration_date": "20261231"}