Ethambutol Hydrochloride (Page 4 of 4)

HOW SUPPLIED

Product: 50090-5142

NDC: 50090-5142-0 100 TABLET in a BOTTLE

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

MADE IN INDIA

Revised: June 2021 ID# 267598

ETHAMBUTOL HYDROCHLORIDE TABLET

Label ImageLabel Image
ETHAMBUTOL HYDROCHLORIDE ethambutol hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-5142(NDC:68180-281)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETHAMBUTOL HYDROCHLORIDE (ETHAMBUTOL) ETHAMBUTOL HYDROCHLORIDE 400 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 4000
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape ROUND (Biconvex) Size 12mm
Flavor Imprint Code L;U;C32
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-5142-0 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078939 07/04/2009
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-5142)

Revised: 06/2021 A-S Medication Solutions

Page 4 of 4 1 2 3 4

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.

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 © 2022. All Rights Reserved.