levetiracetam

Generic: levetiracetam

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler advanced rx of tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levetiracetam 500 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0565
Product ID 80425-0565_45a04d05-6f76-0d6b-e063-6294a90a935d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091491
Listing Expiration 2026-12-31
Marketing Start 2025-12-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250565
Hyphenated Format 80425-0565

Supplemental Identifiers

RxCUI
311289
UNII
44YRR34555
NUI
N0000008486

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 ANDA091491 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 120 TABLET in 1 BOTTLE (80425-0565-1)
  • 30 TABLET in 1 BOTTLE (80425-0565-2)
  • 60 TABLET in 1 BOTTLE (80425-0565-3)
  • 90 TABLET in 1 BOTTLE (80425-0565-4)
source: ndc

Packages (4)

80425-0565-1 120 TABLET in 1 BOTTLE (80425-0565-1) 80425-0565-2 30 TABLET in 1 BOTTLE (80425-0565-2) 80425-0565-3 60 TABLET in 1 BOTTLE (80425-0565-3) 80425-0565-4 90 TABLET in 1 BOTTLE (80425-0565-4)

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": "45a04d05-6f76-0d6b-e063-6294a90a935d", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["311289"], "spl_set_id": ["45a03a43-04db-9138-e063-6394a90a12fa"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET in 1 BOTTLE (80425-0565-1)", "package_ndc": "80425-0565-1", "marketing_start_date": "20251210"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (80425-0565-2)", "package_ndc": "80425-0565-2", "marketing_start_date": "20251210"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (80425-0565-3)", "package_ndc": "80425-0565-3", "marketing_start_date": "20251210"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (80425-0565-4)", "package_ndc": "80425-0565-4", "marketing_start_date": "20251210"}], "brand_name": "Levetiracetam", "product_id": "80425-0565_45a04d05-6f76-0d6b-e063-6294a90a935d", "dosage_form": "TABLET", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "80425-0565", "generic_name": "Levetiracetam", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "500 mg/1"}], "application_number": "ANDA091491", "marketing_category": "ANDA", "marketing_start_date": "20251210", "listing_expiration_date": "20261231"}