levetiracetam

Generic: levetiracetam

Labeler: guardian drug company
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler guardian drug company
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

levetiracetam 100 mg/mL

Manufacturer
Guardian Drug Company

Identifiers & Regulatory

Product NDC 53041-660
Product ID 53041-660_afb5dc0d-459c-441a-bc79-d6a9b5428e10
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218080
Listing Expiration 2026-12-31
Marketing Start 2025-12-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53041660
Hyphenated Format 53041-660

Supplemental Identifiers

RxCUI
403884
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 ANDA218080 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (53041-660-06)
source: ndc

Packages (1)

53041-660-06 473 mL in 1 BOTTLE (53041-660-06)

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": ["ORAL"], "spl_id": "afb5dc0d-459c-441a-bc79-d6a9b5428e10", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["403884"], "spl_set_id": ["e77162ff-0ff9-45ca-95fc-da6ea24ce5a2"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Guardian Drug Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (53041-660-06)", "package_ndc": "53041-660-06", "marketing_start_date": "20251202"}], "brand_name": "Levetiracetam", "product_id": "53041-660_afb5dc0d-459c-441a-bc79-d6a9b5428e10", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "53041-660", "generic_name": "Levetiracetam", "labeler_name": "Guardian Drug Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "100 mg/mL"}], "application_number": "ANDA218080", "marketing_category": "ANDA", "marketing_start_date": "20251202", "listing_expiration_date": "20261231"}