Fenofibrate (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

Fenofibrate tablets, USP are available in two strengths:

48 mg white to off-white, oval-shaped, biconvex, film-coated tablets debossed with ‘ RH37 ’ on one side and other side plain and are available as follows:

  1. NDC 51407-204-90 Bottles of 90

145 mg white to off-white, oval-shaped, biconvex, film-coated tablets debossed with ‘ RH38 ’ on one side and other side plain and are available as follows:

  1. NDC 51407-205-90 Bottles of 90

Storage

Store at 20º — 25º C (68º — 77º 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 tablets, USP.
  • not to use fenofibrate tablets, USP if there is a known hypersensitivity to fenofibrate or fenofibric acid.
  • of medications that should not be taken in combination with fenofibrate tablets, USP.
  • that if they are taking coumarin anticoagulants, fenofibrate tablets, USP 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, USP.
  • to take fenofibrate tablets, USP 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 tablets, USP.
  • 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 tablets, USP and for 5 days after the final dose.

Manufactured by:

Sun Pharmaceutical Industries Ltd.

Mohali, INDIA

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

  1. July 2021 FDA-08

Marketed/Packaged by:

GSMS, Inc.

Camarillo, CA USA 93012

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

NDC 51407-204-90

FENOFIBRATE TABLETS, USP

48 mg

Rx only

90 Tablets

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Package/Label Display Panel

NDC 51407-205-90

FENOFIBRATE TABLETS, USP

145 mg

Rx only

90 Tablets

//medlibrary.org/lib/images-rx/fenofibrate-66/51407-205-90-rev-07-22-300x106.jpg
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FENOFIBRATE
fenofibrate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-204(NDC:63304-448)
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
HYPROMELLOSE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
SODIUM LAURYL SULFATE
SUCROSE
STARCH, CORN
SODIUM STEARYL FUMARATE
SILICON DIOXIDE
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
TALC
LECITHIN, SOYBEAN
XANTHAN GUM
CROSPOVIDONE (15 MPA.S AT 5%)
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL Size 12mm
Flavor Imprint Code RH37
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-204-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200884 09/07/2017
FENOFIBRATE
fenofibrate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-205(NDC:63304-449)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 145 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
SODIUM LAURYL SULFATE
SUCROSE
STARCH, CORN
SILICON DIOXIDE
SODIUM STEARYL FUMARATE
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
TALC
LECITHIN, SOYBEAN
XANTHAN GUM
CROSPOVIDONE (15 MPA.S AT 5%)
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL Size 19mm
Flavor Imprint Code RH38
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-205-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200884 09/07/2017
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 relabel (51407-204), repack (51407-204), relabel (51407-205), repack (51407-205)

Revised: 09/2022 Golden State Medical Supply, Inc.

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