Fenofibrate (Page 5 of 5)

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Manufactured by:

TORRENT PHARMACEUTICALS LTD., INDIA.

Manufactured for:

TORRENT PHARMA INC. Basking Ridge, NJ 07920.

8081291 Rev. 02/2021

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fenofibrate Capsules, USP 67mg  500 counts
(click image for full-size original)
Fenofibrate Capsules, USP 134mg  500 counts
(click image for full-size original)
Fenofibrate Capsules, USP 200mg  500 counts
(click image for full-size original)
FENOFIBRATE fenofibrate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-440
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
CROSPOVIDONE
FD&C BLUE NO. 1
FD&C RED NO. 40
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GELATIN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 3350
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
SODIUM LAURYL SULFATE
SODIUM STEARYL FUMARATE
STARCH, PREGELATINIZED CORN
TITANIUM DIOXIDE
Product Characteristics
Color pink (Opaque) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 1440;67
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-440-01 100 CAPSULE in 1 BOTTLE None
2 NDC:13668-440-74 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (13668-440-71)
2 NDC:13668-440-71 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (13668-440-74)
3 NDC:13668-440-90 90 CAPSULE in 1 BOTTLE None
4 NDC:13668-440-05 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210782 06/03/2021
FENOFIBRATE fenofibrate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-439
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
CROSPOVIDONE
FD&C BLUE NO. 1
FD&C RED NO. 40
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GELATIN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 3350
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
SODIUM LAURYL SULFATE
SODIUM STEARYL FUMARATE
STARCH, PREGELATINIZED CORN
TITANIUM DIOXIDE
Product Characteristics
Color blue (Opaque light) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 1439;134
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-439-90 90 CAPSULE in 1 BOTTLE None
2 NDC:13668-439-01 100 CAPSULE in 1 BOTTLE None
3 NDC:13668-439-05 500 CAPSULE in 1 BOTTLE None
4 NDC:13668-439-74 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (13668-439-71)
4 NDC:13668-439-71 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (13668-439-74)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210782 06/03/2021
FENOFIBRATE fenofibrate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-438
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
CROSPOVIDONE
FD&C BLUE NO. 1
FD&C RED NO. 40
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GELATIN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 3350
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
SODIUM LAURYL SULFATE
SODIUM STEARYL FUMARATE
STARCH, PREGELATINIZED CORN
TITANIUM DIOXIDE
Product Characteristics
Color orange (Opaque) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code 1438;200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-438-90 90 CAPSULE in 1 BOTTLE None
2 NDC:13668-438-01 100 CAPSULE in 1 BOTTLE None
3 NDC:13668-438-05 500 CAPSULE in 1 BOTTLE None
4 NDC:13668-438-74 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (13668-438-71)
4 NDC:13668-438-71 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (13668-438-74)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210782 06/03/2021
Labeler — Torrent Pharmaceuticals Limited (916488547)
Registrant — Torrent Pharma, Inc. (790033935)
Establishment
Name Address ID/FEI Operations
Torrent Pharmaceuticals Limited 864147745 analysis (13668-440), analysis (13668-439), analysis (13668-438), pack (13668-440), pack (13668-439), pack (13668-438), manufacture (13668-440), manufacture (13668-439), manufacture (13668-438), api manufacture (13668-440), api manufacture (13668-439), api manufacture (13668-438)

Revised: 06/2021 Torrent Pharmaceuticals Limited

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