levetiracetam

Generic: levetiracetam

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

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levetiracetam 500 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8843
Product ID 68788-8843_8c16bc7b-672c-420a-a457-350060533375
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091491
Listing Expiration 2026-12-31
Marketing Start 2025-03-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888843
Hyphenated Format 68788-8843

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
  • 100 TABLET in 1 BOTTLE (68788-8843-1)
  • 20 TABLET in 1 BOTTLE (68788-8843-2)
  • 30 TABLET in 1 BOTTLE (68788-8843-3)
  • 60 TABLET in 1 BOTTLE (68788-8843-6)
  • 90 TABLET in 1 BOTTLE (68788-8843-9)
source: ndc

Packages (5)

Ingredients (1)

levetiracetam (500 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "8c16bc7b-672c-420a-a457-350060533375", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["311289"], "spl_set_id": ["8c16bc7b-672c-420a-a457-350060533375"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68788-8843-1)", "package_ndc": "68788-8843-1", "marketing_start_date": "20250320"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (68788-8843-2)", "package_ndc": "68788-8843-2", "marketing_start_date": "20250320"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8843-3)", "package_ndc": "68788-8843-3", "marketing_start_date": "20250320"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-8843-6)", "package_ndc": "68788-8843-6", "marketing_start_date": "20250320"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8843-9)", "package_ndc": "68788-8843-9", "marketing_start_date": "20250320"}], "brand_name": "Levetiracetam", "product_id": "68788-8843_8c16bc7b-672c-420a-a457-350060533375", "dosage_form": "TABLET", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68788-8843", "generic_name": "Levetiracetam", "labeler_name": "Preferred Pharmaceuticals Inc.", "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": "20250320", "listing_expiration_date": "20261231"}