levetiracetam

Generic: levetiracetam

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

Drug Facts

Product Profile

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

levetiracetam 500 mg/1

Manufacturer
Mylan Institutional Inc.

Identifiers & Regulatory

Product NDC 51079-821
Product ID 51079-821_4369847b-77af-cd07-e063-6394a90a9251
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076919
Listing Expiration 2026-12-31
Marketing Start 2008-11-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51079821
Hyphenated Format 51079-821

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 ANDA076919 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (51079-821-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-821-01)
source: ndc

Packages (1)

51079-821-20 100 BLISTER PACK in 1 CARTON (51079-821-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-821-01)

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": "4369847b-77af-cd07-e063-6394a90a9251", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["311289"], "spl_set_id": ["08e1bfea-7f3f-42d9-823d-f75080e664ff"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Mylan Institutional Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (51079-821-20)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-821-01)", "package_ndc": "51079-821-20", "marketing_start_date": "20081104"}], "brand_name": "Levetiracetam", "product_id": "51079-821_4369847b-77af-cd07-e063-6394a90a9251", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "51079-821", "generic_name": "levetiracetam", "labeler_name": "Mylan Institutional Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "500 mg/1"}], "application_number": "ANDA076919", "marketing_category": "ANDA", "marketing_start_date": "20081104", "listing_expiration_date": "20261231"}