levetiracetam

Generic: levetiracetam

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

levetiracetam 100 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-400
Product ID 63323-400_799d949b-b1db-4e10-ab5c-89bf7c1bd308
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090876
Listing Expiration 2026-12-31
Marketing Start 2015-08-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323400
Hyphenated Format 63323-400

Supplemental Identifiers

RxCUI
647121
UPC
0363323400019
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 levetiracetam (source: ndc)
Generic Name levetiracetam (source: ndc)
Application Number ANDA090876 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-USE in 1 TRAY (63323-400-05) / 5 mL in 1 VIAL, SINGLE-USE (63323-400-01)
source: ndc

Packages (1)

63323-400-05 10 VIAL, SINGLE-USE in 1 TRAY (63323-400-05) / 5 mL in 1 VIAL, SINGLE-USE (63323-400-01)

Ingredients (1)

levetiracetam (100 mg/mL)

Linked Drug Pages (2)

Levetiracetam ndc-match (0.9) Levetiracetam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "799d949b-b1db-4e10-ab5c-89bf7c1bd308", "openfda": {"nui": ["N0000008486"], "upc": ["0363323400019"], "unii": ["44YRR34555"], "rxcui": ["647121"], "spl_set_id": ["cc41696c-9cf0-4410-bacc-09132ee805ce"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-USE in 1 TRAY (63323-400-05)  / 5 mL in 1 VIAL, SINGLE-USE (63323-400-01)", "package_ndc": "63323-400-05", "marketing_start_date": "20150813"}], "brand_name": "Levetiracetam", "product_id": "63323-400_799d949b-b1db-4e10-ab5c-89bf7c1bd308", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "63323-400", "generic_name": "LEVETIRACETAM", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "100 mg/mL"}], "application_number": "ANDA090876", "marketing_category": "ANDA", "marketing_start_date": "20150813", "listing_expiration_date": "20261231"}