Letrozole (Page 9 of 9)

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 63629-7819

NDC: 63629-7819-1 30 TABLET, FILM COATED in a BOTTLE

NDC: 63629-7819-2 10 TABLET, FILM COATED in a BOTTLE

NDC: 63629-7819-4 40 TABLET, FILM COATED in a BOTTLE

17 PATIENT COUNSELING INFORMATION

Embryo-Fetal Toxicity

Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during letrozole therapy and for at least 3 weeks after the last dose. Advise females to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, during treatment with letrozole tablets [see Warnings and Precautions ( 5.6), and Use in Specific Populations ( 8.1), ( 8.3)]

Lactation

Advise women not to breastfeed during letrozole tablets treatment and for at least 3 weeks after the last dose [see Use in Specific Populations ( 8.2) .

Infertility

Advise females and males of reproductive potential of the potential for reduced fertility from letrozole tablets [see Use in Specific Populations ( 8.3) .

Fatigue and Dizziness

Since fatigue and dizziness have been observed with the use of letrozole tablets and somnolence was uncommonly reported, caution is advised when driving or using machinery.

Bone Effects Consideration should be given to monitoring bone mineral density.

Manufactured For:
Accord Healthcare, Inc.,
1009 Slater Road,
Suite 210-B,
Durham, NC 27703,
USA.

Manufactured By:
Intas Pharmaceuticals Limited,
Plot No. : 457, 458,
Village – Matoda,
Bavla Road, Ta.- Sanand,
Dist.- Ahmedabad – 382 210. India.

10 2293 1 697339

Issued May 2019

Letrozole 2.5mg Tablet

Label Image
(click image for full-size original)
LETROZOLE letrozole tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-7819(NDC:16729-034)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LETROZOLE (LETROZOLE) LETROZOLE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSE 2910 (6 MPA.S)
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color yellow Score no score
Shape ROUND (biconvex) Size 6mm
Flavor Imprint Code LT
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63629-7819-1 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:63629-7819-2 10 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:63629-7819-4 40 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090934 06/02/2011
Labeler — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (63629-7819), RELABEL (63629-7819)

Revised: 12/2020 Bryant Ranch Prepack

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.