Fenofibrate (Page 7 of 7)

Package/Label Display Panel

NDC 51407-092-90

Fenofibrate Capsules (micronized)

200 mg

Rx only

90 CAPSULES

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FENOFIBRATE fenofibrate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-090(NDC:42858-067)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 67 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
CROSPOVIDONE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE K25
STARCH, CORN
SODIUM LAURYL SULFATE
TALC
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
Product Characteristics
Color pink (Pink Opaque Cap and Body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code RP;067
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-090-90 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075753 09/03/2002
FENOFIBRATE fenofibrate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-091(NDC:42858-134)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 134 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
CROSPOVIDONE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE K25
STARCH, CORN
SODIUM LAURYL SULFATE
TALC
D&C RED NO. 28
FD&C BLUE NO. 1
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
Product Characteristics
Color blue (light blue Opaque Cap and Body) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code RP;134
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-091-90 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075753 04/09/2002
FENOFIBRATE fenofibrate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-092(NDC:42858-200)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 200 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
CROSPOVIDONE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE K25
STARCH, CORN
SODIUM LAURYL SULFATE
TALC
FD&C RED NO. 40
D&C RED NO. 28
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
Product Characteristics
Color orange (Orange Opaque Cap and Body) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code RP;200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-092-90 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075753 04/09/2002
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 relabel (51407-090), repack (51407-090), relabel (51407-091), repack (51407-091), relabel (51407-092), repack (51407-092)

Revised: 06/2021 Golden State Medical Supply, Inc.

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