Fenofibrate (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-5244

NDC: 50090-5244-0 90 TABLET in a BOTTLE

NDC: 50090-5244-1 30 TABLET in a BOTTLE

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 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: 04/2019

fenofibrate

Label ImageLabel Image
FENOFIBRATE fenofibrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-5244(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, UNSPECIFIED
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
EGG PHOSPHOLIPIDS
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:50090-5244-0 90 TABLET in 1 BOTTLE None
2 NDC:50090-5244-1 30 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 — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-5244)

Revised: 10/2020 A-S Medication Solutions

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