levetiracetam

Generic: levetiracetam

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler mylan institutional llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

levetiracetam 10 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-265
Product ID 67457-265_5fc67b72-4c1a-4ea9-8282-07d0a4f4c9e0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202543
Listing Expiration 2026-12-31
Marketing Start 2012-01-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457265
Hyphenated Format 67457-265

Supplemental Identifiers

RxCUI
1193358 1193360 1193362
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 NDA202543 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 BAG in 1 CARTON (67457-265-10) / 100 mL in 1 BAG (67457-265-00)
source: ndc

Packages (1)

67457-265-10 10 BAG in 1 CARTON (67457-265-10) / 100 mL in 1 BAG (67457-265-00)

Ingredients (1)

levetiracetam (10 mg/mL)

Linked Drug Pages (1)

Levetiracetam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "5fc67b72-4c1a-4ea9-8282-07d0a4f4c9e0", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["1193358", "1193360", "1193362"], "spl_set_id": ["70e52e89-3844-4cd9-a406-b29e9520a12c"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BAG in 1 CARTON (67457-265-10)  / 100 mL in 1 BAG (67457-265-00)", "package_ndc": "67457-265-10", "marketing_start_date": "20120116"}], "brand_name": "Levetiracetam", "product_id": "67457-265_5fc67b72-4c1a-4ea9-8282-07d0a4f4c9e0", "dosage_form": "INJECTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "67457-265", "generic_name": "Levetiracetam", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "10 mg/mL"}], "application_number": "NDA202543", "marketing_category": "NDA", "marketing_start_date": "20120116", "listing_expiration_date": "20261231"}