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 INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

levetiracetam 100 mg/mL

Manufacturer
UCB, Inc.

Identifiers & Regulatory

Product NDC 50474-002
Product ID 50474-002_38cabb23-4e04-9a05-e063-6394a90a2a94
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021872
Listing Expiration 2026-12-31
Marketing Start 2006-08-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50474002
Hyphenated Format 50474-002

Supplemental Identifiers

RxCUI
647121 647123
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 NDA021872 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-USE in 1 CARTON (50474-002-63) / 5 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

50474-002-63 10 VIAL, SINGLE-USE in 1 CARTON (50474-002-63) / 5 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

levetiracetam (100 mg/mL)

Linked Drug Pages (1)

Keppra ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "38cabb23-4e04-9a05-e063-6394a90a2a94", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["647121", "647123"], "spl_set_id": ["c6d5784d-abf9-45fe-ac5a-d5c53bd50f7e"], "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": "10 VIAL, SINGLE-USE in 1 CARTON (50474-002-63)  / 5 mL in 1 VIAL, SINGLE-USE", "package_ndc": "50474-002-63", "marketing_start_date": "20060823"}], "brand_name": "Keppra", "product_id": "50474-002_38cabb23-4e04-9a05-e063-6394a90a2a94", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "50474-002", "generic_name": "levetiracetam", "labeler_name": "UCB, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Keppra", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "100 mg/mL"}], "application_number": "NDA021872", "marketing_category": "NDA", "marketing_start_date": "20060823", "listing_expiration_date": "20261231"}