FENOFIBRATE (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Fenofibrate tablets, USP are available in the following strengths and configuration

Fenofibrate tablets, USP are available in the following strengths and configurations:

Fenofibrate tablets, USP 145 mg

White to off white coloured, oval shaped, biconvex film coated tablets, debossed with ‘Cipla’ on one side and code ‘458’ on other side.

Available:

Cartons of 30 tablets (10 tablets per blister pack x 3), NDC 0904-7161-04

Cartons of 100 tablets (10 tablets per blister pack x 10), NDC 0904-7161-61

Storage

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature].

Keep out of the reach of children. Protect from moisture.

17 PATIENT COUNSELING INFORMATION

Patients should be advised:

of the potential benefits and risks of fenofibrate tablets.
not to use fenofibrate tablets if there is a known hypersensitivity to fenofibrate or fenofibric acid.
of medications that should not be taken in combination with fenofibrate tablets.
that if they are taking coumarin anticoagulants, fenofibrate tablets may increase their anti-coagulant effect, and increased monitoring may be necessary.
to continue to follow an appropriate lipid-modifying diet while taking fenofibrate tablets.
to take fenofibrate tablets once daily, without regard to food, at the prescribed dose, swallowing each tablet whole.
to return to their physician’s office for routine monitoring.
to inform their physician of all medications, supplements, and herbal preparations they are taking and any change to their medical condition. Patients should also be advised to inform their physicians prescribing a new medication that they are taking fenofibrate tablets.
to inform their physician of symptoms of liver injury (e.g., jaundice, abdominal pain, nausea, malaise, dark urine, abnormal stool, pruritus); any muscle pain, tenderness, or weakness; or any other new symptoms.
not to breastfeed during treatment with fenofibrate tablets and for 5 days after the final dose.

Manufactured by:

Cipla Ltd,

Indore SEZ, Pithampur, India

Manufactured for:

Cipla USA, Inc.

10 Independence Boulevard, Suite 300

Warren, NJ 07059

Distributed By:

MAJOR® PHARMACEUTICALS

Livonia, MI 48152

Refer to package label for Distributor’s NDC Number

Revised: 6/2021

Package/Label Display Panel

Fenofibrate Tablets, USP

145 mg

100 Tablets

carton label
(click image for full-size original)
FENOFIBRATE fenofibrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-7161(NDC:69097-458)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 145 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE (15 MPA.S AT 5%)
DOCUSATE SODIUM
HYPROMELLOSE 2910 (3 MPA.S)
LACTOSE MONOHYDRATE
LECITHIN, SOYBEAN
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
SODIUM LAURYL SULFATE
SUCROSE
TALC
TITANIUM DIOXIDE
XANTHAN GUM
Product Characteristics
Color WHITE (White to off white) Score no score
Shape OVAL Size 18mm
Flavor Imprint Code Cipla;458
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-7161-04 30 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0904-7161-04)
2 NDC:0904-7161-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0904-7161-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208709 12/15/2016
Labeler — Major Pharmaceuticals (191427277)

Revised: 11/2021 Major Pharmaceuticals

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 © 2024. All Rights Reserved.