keppra xr

Generic: levetiracetam

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

Drug Facts

Product Profile

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

levetiracetam 500 mg/1

Manufacturer
UCB, Inc.

Identifiers & Regulatory

Product NDC 50474-598
Product ID 50474-598_38534148-3717-03b3-e063-6394a90a0f1e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022285
Listing Expiration 2026-12-31
Marketing Start 2008-09-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50474598
Hyphenated Format 50474-598

Supplemental Identifiers

RxCUI
807832 807834 846378 847673
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 xr (source: ndc)
Generic Name levetiracetam (source: ndc)
Application Number NDA022285 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50474-598-66)
source: ndc

Packages (1)

50474-598-66 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50474-598-66)

Ingredients (1)

levetiracetam (500 mg/1)

Linked Drug Pages (1)

Keppra XR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "38534148-3717-03b3-e063-6394a90a0f1e", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["807832", "807834", "846378", "847673"], "spl_set_id": ["2919e43b-69a8-434c-a2d2-1f3ecd7554c0"], "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": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50474-598-66)", "package_ndc": "50474-598-66", "marketing_start_date": "20080924"}], "brand_name": "Keppra XR", "product_id": "50474-598_38534148-3717-03b3-e063-6394a90a0f1e", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "50474-598", "generic_name": "levetiracetam", "labeler_name": "UCB, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Keppra", "brand_name_suffix": "XR", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "500 mg/1"}], "application_number": "NDA022285", "marketing_category": "NDA", "marketing_start_date": "20080924", "listing_expiration_date": "20261231"}