Fenofibrate (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

Fenofibrate tablets, USP are available in two strengths:

54 mg — Light yellow to yellow colored, round-shaped, film-coated tablets debossed “FN1” on one side and plain on other side. Available in bottles of 90 with child-resistant closure (NDC 27241-116-03) and bottles of 500 (NDC 27241-116-05).

160 mg — White to off-white colored, oval-shaped, film-coated tablets debossed “FN2” on one side and plain on other side. Available in bottles of 90 with child-resistant closure (NDC 27241-117-03) and bottles of 500 (NDC 27241-117-05).

Storage

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

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

KEEP THIS AND ALL MEDICATIONS 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 tablet.
• 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 and for 5 days after the final dose.

Marketed by:

Ajanta Pharma USA Inc.
Bridgewater, NJ 08807.

Made in India.

Revised: 03/2021

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 27241-116-03
90 Tablets
Fenofibrate Tablets, USP
54 mg
Rx Only
ajanta

NDC 27241-117-03
90 Tablets
Fenofibrate Tablets, USP
160 mg
Rx Onlyajanta

FENOFIBRATE fenofibrate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27241-116 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 CROSCARMELLOSE SODIUM CROSPOVIDONE FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE LECITHIN, SOYBEAN MICROCRYSTALLINE CELLULOSE POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A CORN SODIUM STEARYL FUMARATE TALC TITANIUM DIOXIDE XANTHAN GUM D&C YELLOW NO. 10

Product Characteristics Color YELLOW Score no score Shape ROUND Size 9mm Flavor Imprint Code FN1 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:27241-116-03 90 TABLET in 1 BOTTLE None 2 NDC:27241-116-05 500 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210138 07/20/2018

FENOFIBRATE fenofibrate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27241-117 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 CROSCARMELLOSE SODIUM CROSPOVIDONE LACTOSE MONOHYDRATE LECITHIN, SOYBEAN MICROCRYSTALLINE CELLULOSE POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A CORN SODIUM STEARYL FUMARATE TALC TITANIUM DIOXIDE XANTHAN GUM

Product Characteristics Color WHITE Score no score Shape OVAL Size 18mm Flavor Imprint Code FN2 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:27241-117-03 90 TABLET in 1 BOTTLE None 2 NDC:27241-117-05 500 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210138 07/20/2018

Labeler — Ajanta Pharma USA Inc. (557554156)

Registrant — Ajanta Pharma Limited (918594859)

Establishment
Name	Address	ID/FEI	Operations
Ajanta Pharma Ltd., Dahej		862199968	MANUFACTURE (27241-116), MANUFACTURE (27241-117)

Establishment
Name	Address	ID/FEI	Operations
Ajanta Pharma Limited		918594859	MANUFACTURE (27241-116), MANUFACTURE (27241-117)

Revised: 12/2021 Ajanta Pharma USA Inc.