levetiracetam solution

Generic: levetiracetam

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam solution
Generic Name levetiracetam
Labeler chartwell rx, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

levetiracetam 100 mg/mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-548
Product ID 62135-548_415b47ab-ba12-2b18-e063-6294a90a2284
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090263
Listing Expiration 2026-12-31
Marketing Start 2009-04-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135548
Hyphenated Format 62135-548

Supplemental Identifiers

RxCUI
403884
UPC
0362135548476
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 solution (source: ndc)
Generic Name levetiracetam (source: ndc)
Application Number ANDA090263 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 2 TRAY in 1 BOX (62135-548-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-548-45)
  • 473 mL in 1 BOTTLE (62135-548-47)
source: ndc

Packages (2)

62135-548-24 2 TRAY in 1 BOX (62135-548-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-548-45) 62135-548-47 473 mL in 1 BOTTLE (62135-548-47)

Ingredients (1)

levetiracetam (100 mg/mL)

Linked Drug Pages (1)

LEVETIRACETAM solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "415b47ab-ba12-2b18-e063-6294a90a2284", "openfda": {"nui": ["N0000008486"], "upc": ["0362135548476"], "unii": ["44YRR34555"], "rxcui": ["403884"], "spl_set_id": ["61eb57a9-5df2-4426-9f0c-a75e2f356b11"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (62135-548-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-548-45)", "package_ndc": "62135-548-24", "marketing_start_date": "20240530"}, {"sample": false, "description": "473 mL in 1 BOTTLE (62135-548-47)", "package_ndc": "62135-548-47", "marketing_start_date": "20220608"}], "brand_name": "LEVETIRACETAM solution", "product_id": "62135-548_415b47ab-ba12-2b18-e063-6294a90a2284", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "62135-548", "generic_name": "LEVETIRACETAM", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVETIRACETAM solution", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "100 mg/mL"}], "application_number": "ANDA090263", "marketing_category": "ANDA", "marketing_start_date": "20090403", "listing_expiration_date": "20261231"}