16 HOW SUPPLIED/STORAGE AND HANDLING
REVATIO tablets are supplied as white, film-coated, round tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows:
|Package Configuration||Strength||NDC||Engraving on Tablet|
|Bottle of 90 Tablets||20 mg||0069-4190-68||RVT20|
Recommended Storage for REVATIO Tablets: Store at controlled room temperature 20°C – 25°C (68°F – 77°F) ; excursions permitted to 15°C – 30°C (59°F –86°F) [see USP Controlled Room Temperature].
REVATIO injection is supplied as a clear, colorless, sterile, ready to use solution containing 10 mg sildenafil/12.5 mL presented in a single-use glass vial.
|Vial individually packaged in a carton||10 mg /12.5 mL||0069-0338-01|
Recommended Storage for REVATIO Injection: Store at controlled room temperature 20°C – 25°C (68°F – 77°F); excursions permitted to 15°C – 30°C (59°F – 86°F) [see USP Controlled Room Temperature].
REVATIO powder for oral suspension is supplied in amber glass bottles. Each bottle contains white to off-white powders containing 1.57 g of sildenafil citrate (equivalent to 1.12 g sildenafil). Following constitution, the volume of the oral suspension is 112 mL (10 mg sildenafil/mL). A 2 mL oral dosing syringe (with 0.5 mL and 2 mL dose markings) and a press-in bottle adaptor are also provided.
|Powder for oral suspension - bottle||10 mg/mL (when reconstituted)||0069-0336-21|
Recommended storage for REVATIO for oral suspension: Store below 30°C (86°F) in the original package in order to protect from moisture.