levetiracetam

Generic: levetiracetam

Labeler: bionpharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler bionpharma inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

levetiracetam 100 mg/mL

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-412
Product ID 69452-412_1d75b15e-881d-a00f-e063-6394a90a4138
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079120
Listing Expiration 2026-12-31
Marketing Start 2024-07-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69452412
Hyphenated Format 69452-412

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 ANDA079120 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (69452-412-88)
source: ndc

Packages (1)

69452-412-88 473 mL in 1 BOTTLE (69452-412-88)

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": "1d75b15e-881d-a00f-e063-6394a90a4138", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["403884"], "spl_set_id": ["1d75b15e-881c-a00f-e063-6394a90a4138"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (69452-412-88)", "package_ndc": "69452-412-88", "marketing_start_date": "20240718"}], "brand_name": "LEVETIRACETAM", "product_id": "69452-412_1d75b15e-881d-a00f-e063-6394a90a4138", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "69452-412", "generic_name": "LEVETIRACETAM", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVETIRACETAM", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "100 mg/mL"}], "application_number": "ANDA079120", "marketing_category": "ANDA", "marketing_start_date": "20240718", "listing_expiration_date": "20261231"}