ALFUZOSIN HYDROCHLORIDE (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alfuzosin Hydrochloride Extended-Release Tablets, 10 mg

label
(click image for full-size original)
ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-021
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALFUZOSIN HYDROCHLORIDE (ALFUZOSIN) ALFUZOSIN HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
HYPROMELLOSES
MAGNESIUM STEARATE
POVIDONE
TALC
SILICON DIOXIDE
Product Characteristics
Color white (white to off white) Score no score
Shape ROUND (Round) Size 10mm
Flavor Imprint Code 1021;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-021-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:13668-021-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:13668-021-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:13668-021-64 90 TABLET, EXTENDED RELEASE in 1 DOSE PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079054 07/18/2011
Labeler — Torrent Pharmaceuticals Limited (916488547)
Registrant — Torrent Pharma, Inc. (790033935)
Establishment
Name Address ID/FEI Operations
Torrent Pharmaceuticals Limited 916488547 analysis (13668-021), pack (13668-021), manufacture (13668-021), api manufacture (13668-021)

Revised: 02/2021 Torrent Pharmaceuticals Limited

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 © 2021. All Rights Reserved.