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 SOLUTION
Routes
ORAL
Active Ingredients

levetiracetam 100 mg/mL

Manufacturer
UCB, Inc.

Identifiers & Regulatory

Product NDC 50474-001
Product ID 50474-001_4974b225-87ca-610e-e063-6294a90ad20a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021505
Listing Expiration 2027-12-31
Marketing Start 2003-10-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50474001
Hyphenated Format 50474-001

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 NDA021505 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE, PLASTIC (50474-001-48)
source: ndc

Packages (1)

50474-001-48 473 mL in 1 BOTTLE, PLASTIC (50474-001-48)

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": ["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": "473 mL in 1 BOTTLE, PLASTIC (50474-001-48)", "package_ndc": "50474-001-48", "marketing_start_date": "20031020"}], "brand_name": "Keppra", "product_id": "50474-001_4974b225-87ca-610e-e063-6294a90ad20a", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "50474-001", "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": "NDA021505", "marketing_category": "NDA", "marketing_start_date": "20031020", "listing_expiration_date": "20271231"}