Fenofibrate (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Fenofibrate Capsules USP are available in two strengths:

50 mg: Size 3 white opaque/white opaque gelatin capsule, imprinted in black ink with “50” between lines on the body, “G 246” on the cap and containing a white to almost white paste, available in bottles of 90 (NDC 62559-460-90).

150 mg: Size 1 white opaque/white opaque gelatin capsule, imprinted in green ink with “150” between lines on the body, “G 248” on the cap and containing a white to almost white paste, available in bottles of 90 (NDC 62559-461-90).

Store at 25ºC; excursions permitted at 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture and light.

17 PATIENT COUNSELING INFORMATION

Patients should be advised:

of the potential benefits and risks of fenofibrate capsules.
not to use fenofibrate capsules if there is a known hypersensitivity to fenofibrate or fenofibric acid.
of medications that should not be taken in combination with fenofibrate capsules.
that if they are taking coumarin anticoagulants, fenofibrate capsules may increase their anti-coagulant effect, and increased monitoring may be necessary.
to inform their physician of all medications, supplements, and herbal preparations they are taking and any change in their medical condition.
to inform a physician prescribing a new medication, that they are taking fenofibrate capsules.
to continue to follow an appropriate lipid-modifying diet while taking fenofibrate capsules.
to take fenofibrate capsules once daily at the prescribed dose, swallowing each capsule whole.
to inform their physician of any muscle pain, tenderness, or weakness; onset of abdominal pain; or any other new symptoms.
not to breastfeed during treatment with fenofibrate capsules and for 5 days after the final dose.
to return to their physician’s office for routine monitoring.

Product of Israel

Manufactured for:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623
ani
9854 Rev 11/19

Package/Label Display Panel

Fenofibrate Capsules USP, 50 mg
NDC 62559-460-90
Rx only
90 Capsules

50-label
(click image for full-size original)

Package/Label Display Panel

Fenofibrate Capsules USP, 150 mg
NDC 62559-461-90
Rx only
90 Capsules

150-label
(click image for full-size original)

FENOFIBRATE fenofibrate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-460
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 50 mg
Inactive Ingredients
Ingredient Name Strength
LAUROYL PEG-32 GLYCERIDES
POLYETHYLENE GLYCOL 20000
POLYETHYLENE GLYCOL 8000
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
SODIUM STARCH GLYCOLATE TYPE A POTATO
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
SHELLAC
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
D&C YELLOW NO. 10
Product Characteristics
Color white (white) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code G;246;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-460-90 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA021612 04/13/2016
FENOFIBRATE fenofibrate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-461
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 150 mg
Inactive Ingredients
Ingredient Name Strength
LAUROYL PEG-32 GLYCERIDES
POLYETHYLENE GLYCOL 20000
POLYETHYLENE GLYCOL 8000
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
SODIUM STARCH GLYCOLATE TYPE A POTATO
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
SHELLAC
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
FD&C BLUE NO. 1
D&C YELLOW NO. 10
Product Characteristics
Color white (white) Score no score
Shape CAPSULE (CAPSULE) Size 19mm
Flavor Imprint Code G;248;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-461-90 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA021612 04/13/2016
Labeler — ANI Pharmaceuticals, Inc. (145588013)
Registrant — Cipher Pharmaceuticals Inc. (200224645)

Revised: 11/2019 ANI Pharmaceuticals, Inc.

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