Prescription Drug Information: Fenofibrate (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

Fenofibrate tablets USP are available in two strengths:

48 mg, white to white-off oval shaped tablets debossed with “LU” on one side and “B21” on the other side.

They are supplied as follows:

NDC 50268-338-12 (10 tablets per card, 2 cards per carton).

145 mg, white to off-white oval shaped tablets debossed with “LU” on one side and “B22” on the other side.

For Institutional Use Only. Dispensed in Unit Dose Package.

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.
  • not to use fenofibrate if there is a known hypersensitivity to fenofibrate or fenofibric acid.
  • of medications that should not be taken in combination with fenofibrate.
  • that if they are taking coumarin anticoagulants, fenofibrate may increase their anti-coagulant effect, and increased monitoring may be necessary.
  • to continue to follow an appropriate lipid-modifying diet while taking fenofibrate.
  • to take fenofibrate 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.
  • 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 and for 5 days after the final dose.

Manufactured for:
AvKARE
Pulaski, TN 38478

Mfg. Rev. 08/20
AV Rev. 08/21(P) AvPAK

20
(click image for full-size original)

FENOFIBRATE fenofibrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-338(NDC:68180-388)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 48 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%)
HYPROMELLOSE 2910 (3 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLACRILIN POTASSIUM
SILICON DIOXIDE
SODIUM LAURYL SULFATE
SUCROSE
Product Characteristics
Color white (off white) Score no score
Shape OVAL (oval) Size 13mm
Flavor Imprint Code LU;B21
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-338-12 20 BLISTER PACK in 1 BOX contains a BLISTER PACK (50268-338-11)
1 NDC:50268-338-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX (50268-338-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090856 09/22/2022
Labeler — AvPAK (832926666)

Revised: 01/2024 AvPAK

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