Felodipine: Package Insert and Label Information (Page 3 of 3)

Geriatric Use

Patients over 65 years of age are likely to develop higher plasma concentrations
of felodipine (see CLINICAL PHARMACOLOGY). In general, dose selection
for an elderly patient should be cautious, usually starting at the low end of the
dosing range (2.5 mg daily). Elderly patients should have their blood pressure
closely monitored during any dosage adjustment.

Patients with Impaired Liver Function

Patients with impaired liver function may have elevated plasma concentrations
of felodipine and may respond to lower doses of felodipine extended-release
tablets; therefore, patients should have their blood pressure monitored closely
during dosage adjustment of felodipine extended-release tablets (see CLINICAL
PHARMACOLOGY).

HOW SUPPLIED

Felodipine Extended-release Tablets, USP are available containing 2.5 mg,
5 mg or 10 mg of felodipine, USP.


The 2.5 mg tablets are white film-coated, round, unscored tablets debossed
with “YSP 211 ”on one side of the tablets. They are available as follows:
NDC 61442-431-01 bottles of 100 tablets
NDC 61442-431-05 bottles of 500 tablets


The 5 mg tablets are orange film-coated, round, unscored tablets debossed
with “YSP 210” on one side of the tablets. They are available as follows:
NDC 61442-432-01 bottles of 100 tablets
NDC 61442-432-05 bottles of 500 tablets


The 10 mg tablets are red film-coated, round, unscored tablets debossed with
“YSP 051” on one side of the tablets. They are available as follows:
NDC 61442-433-01 bottles of 100 tablets
NDC 61442-433-05 bottles of 500 tablets


Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Protect from light.
Dispense in a tight, light-resistant container as defined in the USP using a
child-resistant closure.


Manufactured by:
Yung Shin Pharmaceutical Ind. Co., Ltd.
Tachia, Taichung 43769, TAIWAN


Distributed by:
Carlsbad Technology, Inc.
5922 Farnsworth Court, Carlsbad, CA 92008, USA

Revised: 03/2019

Principal Display Panel – Bottle Label NDC 61442-431-05 Felodipine Tablets Rx Only Carlsbad Technology, Inc. 500 Tablets

image description
(click image for full-size original)

Principal Display Panel – Bottle Label NDC 61442-432-05 Felodipine Tablets Rx Only Carlsbad Technology, Inc. 500 Tablets

image description
(click image for full-size original)

Principal Display Panel – Bottle Label NDC 61442-433-05 Felodipine Tablets Rx Only Carlsbad Technology, Inc. 500 Tablets

image description
(click image for full-size original)

FELODIPINE felodipine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61442-433
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FELODIPINE (FELODIPINE) FELODIPINE 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
HYDROXYPROPYL CELLULOSE (110000 WAMW)
SILICON DIOXIDE
HYPROMELLOSE 2208 (100 MPA.S)
MAGNESIUM STEARATE
BUTYLATED HYDROXYANISOLE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
POLYETHYLENE GLYCOL 1000
TITANIUM DIOXIDE
Product Characteristics
Color red Score no score
Shape ROUND Size 11mm
Flavor Imprint Code YSP211
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61442-433-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:61442-433-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204800 10/12/2020
FELODIPINE felodipine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61442-432
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FELODIPINE (FELODIPINE) FELODIPINE 5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
HYDROXYPROPYL CELLULOSE (110000 WAMW)
SILICON DIOXIDE
HYPROMELLOSE 2208 (100 MPA.S)
MAGNESIUM STEARATE
BUTYLATED HYDROXYANISOLE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
POLYETHYLENE GLYCOL 1000
TITANIUM DIOXIDE
Product Characteristics
Color orange Score no score
Shape ROUND Size 11mm
Flavor Imprint Code YSP210
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61442-432-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:61442-432-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204800 10/12/2020
FELODIPINE felodipine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61442-431
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FELODIPINE (FELODIPINE) FELODIPINE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
HYDROXYPROPYL CELLULOSE (110000 WAMW)
SILICON DIOXIDE
HYPROMELLOSE 2208 (100 MPA.S)
MAGNESIUM STEARATE
BUTYLATED HYDROXYANISOLE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
POLYETHYLENE GLYCOL 1000
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 11mm
Flavor Imprint Code YSP051
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61442-431-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:61442-431-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204800 10/12/2020
Labeler — Carlsbad Technology, Inc. (781047246)
Registrant — Carlsbad Technology, Inc. (781047246)
Establishment
Name Address ID/FEI Operations
Carlsbad Technology, Inc. 781047246 manufacture (61442-431), manufacture (61442-432), manufacture (61442-433)

Revised: 03/2021 Carlsbad Technology, Inc.

Page 3 of 3 1 2 3

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.