Fenofibrate (Page 8 of 8)

Storage

Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture. Dispense in a tight, light-resistant container as defined in USP with a child-resistant closure (as required).

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:

Glenmark Pharmaceuticals Limited

Pithampur, Madhya Pradesh 454755, India

Manufactured for:

Glenmark Pharmaceuticals Inc., USA

Mahwah, NJ 07430

Questions? 1 (888) 721-7115

www.glenmarkpharma-us.com

July 2021

Label Display Panel

NDC 68462-580-01

Fenofibrate Capsules, USP

67 mg

100’s count

Bottle Label

Label Display Panel

NDC 68462-581-01

Fenofibrate Capsules, USP

134 mg

100’s count

Bottle Label

Label Display Panel

NDC 68462-582-01

Fenofibrate Capsules, USP

200 mg

100’s count

Bottle Label

FENOFIBRATE fenofibrate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-580 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 SILICON DIOXIDE CROSPOVIDONE (12 MPA.S AT 5%) LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE K30 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 FERROSOFERRIC OXIDE POTASSIUM HYDROXIDE SHELLAC

Product Characteristics Color PINK (opaque pink cap and body) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code G;580 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68462-580-01 100 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205566 04/07/2017

FENOFIBRATE fenofibrate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-581 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 SILICON DIOXIDE CROSPOVIDONE (12 MPA.S AT 5%) LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE K30 STARCH, CORN SODIUM LAURYL SULFATE TALC D&C RED NO. 28 FD&C BLUE NO. 1 TITANIUM DIOXIDE GELATIN, UNSPECIFIED FERROSOFERRIC OXIDE POTASSIUM HYDROXIDE SHELLAC

Product Characteristics Color BLUE (opaque light blue cap and body) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code G;581 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68462-581-01 100 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205566 04/07/2017

FENOFIBRATE fenofibrate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-582 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 SILICON DIOXIDE CROSPOVIDONE (12 MPA.S AT 5%) LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE K30 STARCH, CORN SODIUM LAURYL SULFATE TALC D&C RED NO. 28 FD&C RED NO. 40 TITANIUM DIOXIDE GELATIN, UNSPECIFIED FERROSOFERRIC OXIDE POTASSIUM HYDROXIDE SHELLAC FERRIC OXIDE YELLOW

Product Characteristics Color ORANGE (opaque orange cap and body) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code G;582 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68462-582-01 100 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205566 04/07/2017

Labeler — Glenmark Pharmaceuticals Inc., USA (130597813)

Establishment
Name	Address	ID/FEI	Operations
Glenmark Pharmaceuticals Limited		862603186	MANUFACTURE (68462-580), MANUFACTURE (68462-581), MANUFACTURE (68462-582), ANALYSIS (68462-580), ANALYSIS (68462-581), ANALYSIS (68462-582)

Revised: 08/2021 Glenmark Pharmaceuticals Inc., USA