ULORIC (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 40mg

NDC 43353-305 — Uloric (Febuxostat) 40mg — Rx OnlyBottle Label 40mg

ULORIC febuxostat tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43353-305(NDC:64764-918)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
febuxostat (febuxostat) febuxostat 40 mg
Inactive Ingredients
Ingredient Name Strength
lactose monohydrate
MICROCRYSTALLINE CELLULOSE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
croscarmellose sodium
silicon dioxide
magnesium stearate
Product Characteristics
Color GREEN (light green to green) Score no score
Shape ROUND (round shaped) Size 9mm
Flavor Imprint Code TAP;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43353-305-60 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021856 02/13/2009
Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, LLC 128385585 REPACK (43353-305)

Revised: 12/2019 Aphena Pharma Solutions — Tennessee, LLC

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

https://medlibrary.org/lib/rx/meds/uloric-6/page/6/

Clinical Trials

MedLibrary.org

Medication Sections

RSS Feeds

About

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2023. All Rights Reserved.