Fenofibrate (Page 6 of 6)

HOW SUPPLIED

Fenofibrate capsules, USP (micronized), 67 mg are hard gelatin capsule shells with pink opaque cap and pink opaque body imprinted IG and 470 with black ink. They are supplied as follows:

NDC 69097-894-02 Bottles of 30 capsules
NDC 69097-894-07 Bottles of 100 capsules
NDC 69097-894-15 Bottles of 1,000 capsules

Fenofibrate capsules, USP (micronized), 134 mg are hard gelatin capsule shells with blue opaque cap and blue opaque body imprinted IG and 471 with black ink. They are supplied as follows:

NDC 69097-895-02 Bottles of 30 capsules
NDC 69097-895-07 Bottles of 100 capsules
NDC 69097-895-12 Bottles of 500 capsules

Fenofibrate capsules, USP (micronized), 200 mg are hard gelatin capsule shells with orange opaque cap and orange opaque body imprinted IG and 472 with black ink. They are supplied as follows:

NDC 69097-896-02 Bottles of 30 capsules
NDC 69097-896-07 Bottles of 100 capsules
NDC 69097-896-12 Bottles of 500 capsules

STORAGE

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.

REFERENCES

1.GOLDBERG AC, et al. Fenofibrate for the Treatment of Type IV and V Hyperlipoproteinemias: A Double-Blind, Placebo-Controlled Multicenter US Study. Clinical Therapeutics, 11, pp. 69-83, 1989.2.NIKKILA EA. Familial Lipoprotein Lipase Deficiency and Related Disorders of Chylomicron Metabolism. In Stanbury J.B., et al. (eds.): The Metabolic Basis of Inherited Disease, 5th edition, McGraw-Hill, 1983, Chap. 30, pp. 622-642.3.BROWN WV, et al. Effects of Fenofibrate on Plasma Lipids: Double-Blind, Multicenter Study In Patients with Type IIA or IIB Hyperlipidemia. Arteriosclerosis. 6, pp. 670-678, 1986.

Manufactured by:
InvaGen Pharmaceuticals, Inc.
(a subsidiary of Cipla Ltd.)
Hauppauge, NY 11788

Manufactured for:
Cipla USA, Inc.
10 Independence Boulevard, Suite 300
Warren, NJ 07059

Revised: 05/2020

PRINCIPAL DISPLAY PANEL — 67 mg

NDC 69097-894-07 Rx Only

Fenofibrate
Capsules, USP
67 mg 100 Capsules

Cipla

Fenofibrate Capsules, USP 200 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 134 mg

NDC 69097-895-07 Rx Only

Fenofibrate
Capsules, USP
134 mg 100 Capsules

Cipla

Fenofibrate Capsules, USP 200 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 200 mg

NDC 69097-896-07 Rx Only

Fenofibrate
Capsules, USP
200 mg 100 Capsules

Cipla

Fenofibrate Capsules, USP 200 mg Bottle Label
(click image for full-size original)
FENOFIBRATE fenofibrate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-894
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
LACTOSE MONOHYDRATE
CROSPOVIDONE, UNSPECIFIED
POVIDONE, UNSPECIFIED
SODIUM LAURYL SULFATE
SILICON DIOXIDE
MAGNESIUM STEARATE
FD&C BLUE NO. 1
FD&C RED NO. 3
D&C YELLOW NO. 10
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
Product Characteristics
Color PINK (Pink opaque cap) , PINK (Pink opaque body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code IG;470
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69097-894-02 30 CAPSULE in 1 BOTTLE, PLASTIC None
2 NDC:69097-894-07 100 CAPSULE in 1 BOTTLE, PLASTIC None
3 NDC:69097-894-15 1000 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207378 03/30/2017
FENOFIBRATE fenofibrate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-895
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
LACTOSE MONOHYDRATE
CROSPOVIDONE, UNSPECIFIED
POVIDONE, UNSPECIFIED
SODIUM LAURYL SULFATE
SILICON DIOXIDE
MAGNESIUM STEARATE
FD&C BLUE NO. 1
D&C RED NO. 28
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
Product Characteristics
Color BLUE (Blue opaque cap) , BLUE (Blue opaque body) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code IG;471
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69097-895-02 30 CAPSULE in 1 BOTTLE, PLASTIC None
2 NDC:69097-895-07 100 CAPSULE in 1 BOTTLE, PLASTIC None
3 NDC:69097-895-12 500 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207378 03/30/2017
FENOFIBRATE fenofibrate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-896
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
LACTOSE MONOHYDRATE
CROSPOVIDONE, UNSPECIFIED
POVIDONE, UNSPECIFIED
SODIUM LAURYL SULFATE
SILICON DIOXIDE
MAGNESIUM STEARATE
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
Product Characteristics
Color ORANGE (Orange opaque cap) , ORANGE (Orange opaque body) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code IG;472
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69097-896-02 30 CAPSULE in 1 BOTTLE, PLASTIC None
2 NDC:69097-896-07 100 CAPSULE in 1 BOTTLE, PLASTIC None
3 NDC:69097-896-12 500 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207378 03/30/2017
Labeler — Cipla USA Inc., (078719707)
Registrant — Cipla USA Inc., (078719707)
Establishment
Name Address ID/FEI Operations
InvaGen Pharmaceuticals Inc. 165104469 manufacture (69097-894), manufacture (69097-895), manufacture (69097-896), analysis (69097-894), analysis (69097-895), analysis (69097-896)
Establishment
Name Address ID/FEI Operations
InvaGen Pharmaceuticals Inc. 080334903 analysis (69097-894), analysis (69097-895), analysis (69097-896), pack (69097-894), pack (69097-895), pack (69097-896)

Revised: 01/2023 Cipla USA Inc.,

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2023. All Rights Reserved.