Fenofibrate: Package Insert and Label Information (Page 3 of 3)

HOW SUPPLIED

Fenofibrate capsules, USP (micronized) 67 mg are opaque white cap and body, hard gelatin capsules, printed in black ink “CL” and “22” on opposing cap and body portions of the capsule. They are supplied as follows:

NDC 69367-270-01 Bottles of 100 capsules

Fenofibrate capsules, USP (micronized) 134 mg are opaque white cap and opaque yellow body, hard gelatin capsules, printed in black ink “CL” and “23” on opposing cap and body portions of the capsule. They are supplied as follows:

NDC 69367-268-01 Bottles of 100 capsules

Fenofibrate capsules, USP (micronized) 200 mg are opaque yellow cap and body, hard gelatin capsules, printed in black ink “CL” and “24” on opposing cap and body portions of the capsule. They are supplied as follows:

NDC 69367-269-01 Bottles of 100 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. Dispense in 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 Therapeutic s, 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.

Distributed by:

Westminster Pharmaceuticals, LLC

Nashville, TN 37217

Revised: 10/2020

LBL387

PRINCIPAL DISPLAY PANEL — 67 mg Capsule Bottle Label

NDC 69367- 270 -01

Fenofibrate Capsules, USP

67 mg

Rx Only 100 Capsules

67mg-100ct-wp
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 134 mg Capsule Bottle Label

NDC 69367- 268 -01

Fenofibrate Capsules, USP

134 mg

Rx Only 100 Capsules

134mg-100ct-wp
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 200 mg Capsule Bottle Label

NDC 69367- 269 -01

Fenofibrate Capsules, USP

200 mg

Rx Only 100 Capsules

200mg-100ct-wp
(click image for full-size original)

FENOFIBRATE
fenofibrate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-270
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 67 mg
Product Characteristics
Color white (opaque white) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code CL;22
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-270-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207805 11/20/2020
FENOFIBRATE
fenofibrate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-268
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 134 mg
Product Characteristics
Color white (white-cap) , yellow (yellow-body) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code CL;23
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-268-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207805 11/20/2020
FENOFIBRATE
fenofibrate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-269
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 200 mg
Product Characteristics
Color yellow Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code CL;24
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-269-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207805 11/20/2020
Labeler — Westminster Pharmaceuticals, LLC (079516651)
Establishment
Name Address ID/FEI Operations
Austarpharma, LLC 362785011 manufacture (69367-270), manufacture (69367-268), manufacture (69367-269)

Revised: 12/2020 Westminster Pharmaceuticals, LLC

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