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, FILM COATED
Routes
ORAL
Active Ingredients

levetiracetam 500 mg/1

Manufacturer
Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-8254
Product ID 68788-8254_dbbfc67e-e438-40f9-bbee-56f0d0e25a29
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078154
Listing Expiration 2026-12-31
Marketing Start 2022-09-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888254
Hyphenated Format 68788-8254

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 ANDA078154 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68788-8254-1)
  • 20 TABLET, FILM COATED in 1 BOTTLE (68788-8254-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8254-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8254-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8254-9)
source: ndc

Packages (5)

68788-8254-1 100 TABLET, FILM COATED in 1 BOTTLE (68788-8254-1) 68788-8254-2 20 TABLET, FILM COATED in 1 BOTTLE (68788-8254-2) 68788-8254-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8254-3) 68788-8254-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8254-6) 68788-8254-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8254-9)

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": "dbbfc67e-e438-40f9-bbee-56f0d0e25a29", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["311289"], "spl_set_id": ["e31c6830-4647-4481-b4f1-494a52c48b1b"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68788-8254-1)", "package_ndc": "68788-8254-1", "marketing_start_date": "20220902"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (68788-8254-2)", "package_ndc": "68788-8254-2", "marketing_start_date": "20220902"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8254-3)", "package_ndc": "68788-8254-3", "marketing_start_date": "20220902"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8254-6)", "package_ndc": "68788-8254-6", "marketing_start_date": "20220902"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8254-9)", "package_ndc": "68788-8254-9", "marketing_start_date": "20220902"}], "brand_name": "Levetiracetam", "product_id": "68788-8254_dbbfc67e-e438-40f9-bbee-56f0d0e25a29", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68788-8254", "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": "ANDA078154", "marketing_category": "ANDA", "marketing_start_date": "20220902", "listing_expiration_date": "20261231"}