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
PRINCIPAL DISPLAY PANEL — 134 mg
NDC 69097-895-07 Rx Only
Fenofibrate
Capsules, USP
134 mg 100 Capsules
Cipla
PRINCIPAL DISPLAY PANEL — 200 mg
NDC 69097-896-07 Rx Only
Fenofibrate
Capsules, USP
200 mg 100 Capsules
Cipla
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FENOFIBRATE fenofibrate capsule | ||||||||||||||||||||||||
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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.,
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