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Fidaxomicin how supplied

Introduction

Fidaxomicin
DIFICID ® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages
How Supplied

How Supplied

DIFICID tablets are white to off-white film-coated, oblong tablets containing 200 mg of fidaxomicin; each tablet is debossed with “FDX” on one side and “200” on the other side.

DIFICID tablets are supplied as

Bottles of 20 tablets, (NDC 52015-080-01) Bottles of 60 tablets, (NDC 52015-080-02) 10 tablet aluminum blister cards, with 10 cards per carton, (NDC 52015-080-12)

Storage

Store at 20°C-25°C (68°F-77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).

See USP Controlled Room Temperature.[1]

References

References

Adapted from the FDA Package Insert.

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]