Dutasteride and Tamsulosin Hydrochloride

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE- dutasteride and tamsulosin hydrochloride capsule
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1356-3

Dutasteride and tamsulosin hydrochloride Capsules, 0.4/0.5 mg

Rx only

30 Capsules

Dutasteride and tamsulosin hydrochloride capsules
(click image for full-size original)
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
dutasteride and tamsulosin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1356
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DUTASTERIDE (DUTASTERIDE) DUTASTERIDE 0.5 mg
TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN) TAMSULOSIN HYDROCHLORIDE 0.4 mg
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
AMMONIA
BUTYL ALCOHOL
BUTYLATED HYDROXYTOLUENE
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES
CARRAGEENAN
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GELATIN
GLYCERIN
HYPROMELLOSES
ISOPROPYL ALCOHOL
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
METHYLPARABEN
POTASSIUM CHLORIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
PROPYLPARABEN
SHELLAC
TALC
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color YELLOW (OPAQUE YELLOW CAP) , WHITE (OPAQUE WHITE BODY) Score no score
Shape CAPSULE (CAPSULE) Size 23mm
Flavor Imprint Code 640
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1356-3 30 CAPSULE in 1 BOTTLE None
2 NDC:70771-1356-9 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207769 06/04/2018
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (70771-1356), MANUFACTURE (70771-1356)

Revised: 08/2020 Cadila Healthcare 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.