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FENOFIBRATE capsule


  1. Patients Should Be Advised:
  2. Revised: 5/2014document Id:
  3. Manufactured For:

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.
  • to return to their physician's office for routine monitoring.

Product of Israel

Manufactured into capsules by:
Galephar Pharmaceutical Research Inc.
Humacao, PR 00792

Manufactured for:
H2-Pharma, LLC
Montgomery, AL 36117

H2pharma

Principal Display Panel 50 mg Bottle Label

NDC 61269-210-90

Fenofibrate Capsules, USP

50 mg

Rx Only

H2-Pharma

90 Capsules

Principal Display Panel     50 mg Bottle Label

Principal Display Panel 150 mg Bottle Label

NDC 61269-212-90

Fenofibrate Capsules, USP

150 mg

Rx Only

H2-Pharma

90 Capsules

Principal Display Panel     150 mg Bottle Label
FENOFIBRATE
fenofibrate capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61269-210
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FENOFIBRATE(UNII: U202363UOS) (FENOFIBRATE - UNII:U202363UOS)FENOFIBRATE50 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Colorwhite (white)Scoreno score
ShapeCAPSULE (CAPSULE)Size16mm
FlavorImprint CodeG;246;50
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61269-210-9090 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02161205/05/2014
FENOFIBRATE
fenofibrate capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61269-212
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FENOFIBRATE(UNII: U202363UOS) (FENOFIBRATE - UNII:U202363UOS)FENOFIBRATE150 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Colorwhite (white)Scoreno score
ShapeCAPSULE (CAPSULE)Size19mm
FlavorImprint CodeG;248;150
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61269-212-9090 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02161205/05/2014
Labeler -H2-Pharma, LLC (028473634)
Registrant -Galephar Pharmaceutical Research Inc. (968996160)
Establishment
NameAddressID/FEIBusiness Operations
Chemagis Ltd.600077101API MANUFACTURE(61269-210, 61269-212)
Establishment
NameAddressID/FEIBusiness Operations
Galephar Pharmaceutical Research Inc.003551624MANUFACTURE(61269-210, 61269-212) , ANALYSIS(61269-210, 61269-212) , PACK(61269-210, 61269-212)
Establishment
NameAddressID/FEIBusiness Operations
Galephar Pharmaceutical Research Inc.968996160MANUFACTURE(61269-210, 61269-212) , ANALYSIS(61269-210, 61269-212) , PACK(61269-210, 61269-212) , LABEL(61269-210, 61269-212)

Revised: 5/2014document Id: 

8da243b2-fa62-4e6f-a064-12d15e0eda29Set id: 6d8a9e4f-8d3b-48f2-8379-361db685e1d3Version: 1Effective Time: 20140501H2-Pharma, LLC

Manufactured For: 

Apotex Inc.Apotex Corp.Toronto, ONWeston, FloridaCanada, M9L 1T933326

Revised: October 2019

Rev. 9



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