levetiracetam

Generic: levetiracetam

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

Drug Facts

Product Profile

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

levetiracetam 1000 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-5619
Product ID 0378-5619_8eaa3318-fe96-4d3e-9f49-3286cb04bfbf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090261
Listing Expiration 2026-12-31
Marketing Start 2009-12-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03785619
Hyphenated Format 0378-5619

Supplemental Identifiers

RxCUI
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 ANDA090261 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5619-91)
source: ndc

Packages (1)

0378-5619-91 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5619-91)

Ingredients (1)

levetiracetam (1000 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": "8eaa3318-fe96-4d3e-9f49-3286cb04bfbf", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["311289", "311290", "387003"], "spl_set_id": ["0a987d59-560f-4650-96ec-31aec81953b5"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5619-91)", "package_ndc": "0378-5619-91", "marketing_start_date": "20091210"}], "brand_name": "Levetiracetam", "product_id": "0378-5619_8eaa3318-fe96-4d3e-9f49-3286cb04bfbf", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "0378-5619", "generic_name": "levetiracetam", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "1000 mg/1"}], "application_number": "ANDA090261", "marketing_category": "ANDA", "marketing_start_date": "20091210", "listing_expiration_date": "20261231"}