levetiracetam

Generic: levetiracetam

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

Drug Facts

Product Profile

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

levetiracetam 100 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-790
Product ID 67457-790_2ca3030b-a3e6-4a6e-ae71-adceaf27c545
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203308
Listing Expiration 2026-12-31
Marketing Start 2017-07-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457790
Hyphenated Format 67457-790

Supplemental Identifiers

RxCUI
647121
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 ANDA203308 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-790-05) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-790-00)
source: ndc

Packages (1)

67457-790-05 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-790-05) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-790-00)

Ingredients (1)

levetiracetam (100 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": "2ca3030b-a3e6-4a6e-ae71-adceaf27c545", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["647121"], "spl_set_id": ["e86dc508-4d22-493b-bdf1-408b6484d3f1"], "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 VIAL, SINGLE-DOSE in 1 CARTON (67457-790-05)  / 5 mL in 1 VIAL, SINGLE-DOSE (67457-790-00)", "package_ndc": "67457-790-05", "marketing_start_date": "20170724"}], "brand_name": "levetiracetam", "product_id": "67457-790_2ca3030b-a3e6-4a6e-ae71-adceaf27c545", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "67457-790", "generic_name": "levetiracetam", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "100 mg/mL"}], "application_number": "ANDA203308", "marketing_category": "ANDA", "marketing_start_date": "20170724", "listing_expiration_date": "20261231"}