levetiracetam

Generic: levetiracetam

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler bluepoint laboratories
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levetiracetam 750 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-404
Product ID 68001-404_28d8b606-37b2-642c-e063-6294a90ad080
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078993
Listing Expiration 2026-12-31
Marketing Start 2019-06-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001404
Hyphenated Format 68001-404

Supplemental Identifiers

RxCUI
311288 311289 311290 387003
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 ANDA078993 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (68001-404-03)
  • 120 TABLET, FILM COATED in 1 BOTTLE (68001-404-07)
source: ndc

Packages (2)

68001-404-03 500 TABLET, FILM COATED in 1 BOTTLE (68001-404-03) 68001-404-07 120 TABLET, FILM COATED in 1 BOTTLE (68001-404-07)

Ingredients (1)

levetiracetam (750 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": "28d8b606-37b2-642c-e063-6294a90ad080", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["311288", "311289", "311290", "387003"], "spl_set_id": ["8b74b8bc-d95c-4471-8f74-c3117243bf89"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (68001-404-03)", "package_ndc": "68001-404-03", "marketing_start_date": "20190619"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (68001-404-07)", "package_ndc": "68001-404-07", "marketing_start_date": "20190619"}], "brand_name": "Levetiracetam", "product_id": "68001-404_28d8b606-37b2-642c-e063-6294a90ad080", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68001-404", "generic_name": "Levetiracetam", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "750 mg/1"}], "application_number": "ANDA078993", "marketing_category": "ANDA", "marketing_start_date": "20190619", "listing_expiration_date": "20261231"}