Fenofibrate (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

Fenofibrate tablets, USP are available in two strengths:

Fenofibrate tablets, USP 54 mg are white to off-white, oval-shaped, biconvex, film-coated tablets, debossed with “RX900 ” on one side and plain on the other side. They are supplied as follows.

NDC 16714-162-01 Bottles of 90

Fenofibrate tablets, USP 160 mg are white to off-white, oval-shaped, biconvex, film-coated tablets, debossed with “RX901 ” on one side and plain on the other side. They are supplied as follows:

NDC 16714-163-01 Bottles of 90

NDC 16714-163-02 Bottles of 500

Storage

Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Protect from moisture.

Keep this and all medication out of the reach of children.

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 with a meal 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, abnormal pain,

nausea, malaise, dark urine, abnormal stool, pruritus); any muscle pain, tenderness, or weakness; onset of abdominal pain; or any other new symptoms.

not to breastfeed during treatment with fenofibrate tablets and for 5 days after the final dose.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For more information call Northstar Rx LLC at 1-800-206-7821.

Manufactured for:

NorthStar Rx LLC

Memphis, TN 38141

Manufactured by:

Sun Pharmaceutical Industries Limited,

Mohali, INDIA

February 2021 FDA-01

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Click here to enter Display Panel

Package/Label Display Panel

NDC 16714-162-01

Fenofibrate Tablets, USP

54 mg

Rx only

90 Tablets

spl-northstar-label1
(click image for full-size original)

Package/Label Display Panel

NDC 16714-163-01

Fenofibrate Tablets, USP

160 mg

Rx only

90 Tablets

spl-northstar-label2
(click image for full-size original)
FENOFIBRATE
fenofibrate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-162
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 54 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
POLYVINYL ALCOHOL, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
STARCH, CORN
SODIUM LAURYL SULFATE
SODIUM STEARYL FUMARATE
TALC
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL (biconvex) Size 12mm
Flavor Imprint Code RX900
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-162-01 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076635 05/10/2021
FENOFIBRATE
fenofibrate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-163
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 160 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
POLYVINYL ALCOHOL, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
STARCH, CORN
SODIUM LAURYL SULFATE
SODIUM STEARYL FUMARATE
TALC
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL (biconvex) Size 18mm
Flavor Imprint Code RX901
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-163-01 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:16714-163-02 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076635 05/10/2021
Labeler — NORTHSTAR RXLLC (830546433)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 650456002 MANUFACTURE (16714-162), MANUFACTURE (16714-163)

Revised: 05/2021 NORTHSTAR RXLLC

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