levetiracetam

Generic: levetiracetam

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler cardinal health 107, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

levetiracetam 100 mg/mL

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-4316
Product ID 55154-4316_b404ceca-0c91-40a1-af05-0f44ed923ef7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201157
Listing Expiration 2026-12-31
Marketing Start 2015-06-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 551544316
Hyphenated Format 55154-4316

Supplemental Identifiers

RxCUI
403884
UPC
0055154431651
UNII
44YRR34555
NUI
N0000008486

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 ANDA201157 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 5 CUP, UNIT-DOSE in 1 BAG (55154-4316-5) / 5 mL in 1 CUP, UNIT-DOSE
source: ndc

Packages (1)

55154-4316-5 5 CUP, UNIT-DOSE in 1 BAG (55154-4316-5) / 5 mL in 1 CUP, UNIT-DOSE

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": "b404ceca-0c91-40a1-af05-0f44ed923ef7", "openfda": {"nui": ["N0000008486"], "upc": ["0055154431651"], "unii": ["44YRR34555"], "rxcui": ["403884"], "spl_set_id": ["a91defd2-486b-4995-ba4c-640525ab575d"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "5 CUP, UNIT-DOSE in 1 BAG (55154-4316-5)  / 5 mL in 1 CUP, UNIT-DOSE", "package_ndc": "55154-4316-5", "marketing_start_date": "20230801"}], "brand_name": "Levetiracetam", "product_id": "55154-4316_b404ceca-0c91-40a1-af05-0f44ed923ef7", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "55154-4316", "generic_name": "LEVETIRACETAM", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "100 mg/mL"}], "application_number": "ANDA201157", "marketing_category": "ANDA", "marketing_start_date": "20150604", "listing_expiration_date": "20261231"}