levetiracetam

Generic: levetiracetam

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

levetiracetam 500 mg/5mL

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-120
Product ID 72205-120_e1381fe9-298e-47e3-996c-808e0a9dd643
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215980
Listing Expiration 2026-12-31
Marketing Start 2022-11-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72205120
Hyphenated Format 72205-120

Supplemental Identifiers

RxCUI
647121
UPC
0372205120013
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 ANDA215980 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/5mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (72205-120-07) / 5 mL in 1 VIAL
  • 25 VIAL in 1 CARTON (72205-120-25) / 5 mL in 1 VIAL
source: ndc

Packages (2)

Ingredients (1)

levetiracetam (500 mg/5mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "e1381fe9-298e-47e3-996c-808e0a9dd643", "openfda": {"nui": ["N0000008486"], "upc": ["0372205120013"], "unii": ["44YRR34555"], "rxcui": ["647121"], "spl_set_id": ["484e8d8f-be40-46f8-a509-d1bbdbbd2981"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (72205-120-07)  / 5 mL in 1 VIAL", "package_ndc": "72205-120-07", "marketing_start_date": "20230209"}, {"sample": false, "description": "25 VIAL in 1 CARTON (72205-120-25)  / 5 mL in 1 VIAL", "package_ndc": "72205-120-25", "marketing_start_date": "20230209"}], "brand_name": "Levetiracetam", "product_id": "72205-120_e1381fe9-298e-47e3-996c-808e0a9dd643", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "72205-120", "generic_name": "Levetiracetam", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "500 mg/5mL"}], "application_number": "ANDA215980", "marketing_category": "ANDA", "marketing_start_date": "20221115", "listing_expiration_date": "20261231"}