keppra

Generic: levetiracetam

Labeler: ucb, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

levetiracetam 500 mg/1

Manufacturer
UCB, Inc.

Identifiers & Regulatory

Product NDC 50474-595
Product ID 50474-595_4974b225-87ca-610e-e063-6294a90ad20a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021035
Listing Expiration 2027-12-31
Marketing Start 2000-04-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50474595
Hyphenated Format 50474-595

Supplemental Identifiers

RxCUI
261335 261336 284391 311288 311289 311290 387003 403884 404595 630807
UPC
0350474595404
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 keppra (source: ndc)
Generic Name levetiracetam (source: ndc)
Application Number NDA021035 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50474-595-40)
source: ndc

Packages (1)

50474-595-40 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50474-595-40)

Ingredients (1)

levetiracetam (500 mg/1)

Linked Drug Pages (1)

Keppra ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4974b225-87ca-610e-e063-6294a90ad20a", "openfda": {"nui": ["N0000008486"], "upc": ["0350474595404"], "unii": ["44YRR34555"], "rxcui": ["261335", "261336", "284391", "311288", "311289", "311290", "387003", "403884", "404595", "630807"], "spl_set_id": ["3ca9df05-a506-4ec8-a4fe-320f1219ab21"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["UCB, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50474-595-40)", "package_ndc": "50474-595-40", "marketing_start_date": "20000424"}], "brand_name": "Keppra", "product_id": "50474-595_4974b225-87ca-610e-e063-6294a90ad20a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "50474-595", "generic_name": "levetiracetam", "labeler_name": "UCB, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Keppra", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "500 mg/1"}], "application_number": "NDA021035", "marketing_category": "NDA", "marketing_start_date": "20000424", "listing_expiration_date": "20271231"}