Fidaxomicin how supplied

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

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

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.

References

Adapted from the FDA Package Insert.