levetiracetam

Generic: levetiracetam

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

levetiracetam 500 mg/5mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-177
Product ID 55150-177_c343dddb-d9b2-4b06-ae2f-aa54a9004e3e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204312
Listing Expiration 2026-12-31
Marketing Start 2016-02-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150177
Hyphenated Format 55150-177

Supplemental Identifiers

RxCUI
647121
UPC
0355150177059
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 ANDA204312 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/5mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-177-05) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55150-177-05 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-177-05) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

levetiracetam (500 mg/5mL)

Linked Drug Pages (1)

Levetiracetam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "c343dddb-d9b2-4b06-ae2f-aa54a9004e3e", "openfda": {"nui": ["N0000008486"], "upc": ["0355150177059"], "unii": ["44YRR34555"], "rxcui": ["647121"], "spl_set_id": ["3e43c17f-7e7e-4ccd-b321-1dd5e62cdafd"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (55150-177-05)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-177-05", "marketing_start_date": "20160201"}], "brand_name": "Levetiracetam", "product_id": "55150-177_c343dddb-d9b2-4b06-ae2f-aa54a9004e3e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "55150-177", "generic_name": "Levetiracetam", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "500 mg/5mL"}], "application_number": "ANDA204312", "marketing_category": "ANDA", "marketing_start_date": "20160201", "listing_expiration_date": "20261231"}