levetiracetam

Generic: levetiracetam

Labeler: prinston pharmaceutical inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler prinston pharmaceutical inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levetiracetam 250 mg/1

Manufacturer
Prinston Pharmaceutical Inc.

Identifiers & Regulatory

Product NDC 76494-528
Product ID 76494-528_bf716ab6-d438-4a19-8193-dbc05b4eabad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078106
Listing Expiration 2026-12-31
Marketing Start 2012-09-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76494528
Hyphenated Format 76494-528

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 ANDA078106 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE (76494-528-12)
source: ndc

Packages (1)

76494-528-12 120 TABLET, FILM COATED in 1 BOTTLE (76494-528-12)

Ingredients (1)

levetiracetam (250 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": "bf716ab6-d438-4a19-8193-dbc05b4eabad", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["311288", "311289", "311290", "387003"], "spl_set_id": ["d818ef84-9b3e-434b-92d9-910cfa8af7da"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Prinston Pharmaceutical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (76494-528-12)", "package_ndc": "76494-528-12", "marketing_start_date": "20120911"}], "brand_name": "Levetiracetam", "product_id": "76494-528_bf716ab6-d438-4a19-8193-dbc05b4eabad", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "76494-528", "generic_name": "Levetiracetam", "labeler_name": "Prinston Pharmaceutical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "250 mg/1"}], "application_number": "ANDA078106", "marketing_category": "ANDA", "marketing_start_date": "20120911", "listing_expiration_date": "20261231"}