revatio
Generic: sildenafil citrate
Labeler: viatris specialty llcDrug Facts
Product Profile
Brand Name
revatio
Generic Name
sildenafil citrate
Labeler
viatris specialty llc
Dosage Form
TABLET, FILM COATED
Routes
Active Ingredients
sildenafil citrate 20 mg/1
Manufacturer
Identifiers & Regulatory
Product NDC
58151-402
Product ID
58151-402_3fa2b889-ff04-4db1-b2c8-c0238efe240b
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
NDA
Application Number
NDA021845
Listing Expiration
2026-12-31
Marketing Start
2024-10-25
Pharmacologic Class
Classes
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
58151402
Hyphenated Format
58151-402
Supplemental Identifiers
RxCUI
UNII
Packaging Origin
Original Packager
Resolved Product View
Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.
Resolved Identity
Brand Name
revatio (source: ndc)
Generic Name
sildenafil citrate (source: ndc)
Application Number
NDA021845 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 20 mg/1
Packaging
- 16 HOW SUPPLIED/STORAGE AND HANDLING REVATIO tablets are supplied as white to off-white, film-coated, round tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows: REVATIO Tablets Package Configuration Strength NDC Engraving on Tablet Bottle of 90 Tablets 20 mg 58151-402-77 “RVT 20” on one side and “VLE” on the other side Recommended Storage for REVATIO Tablets: Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 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 (0.8 mg/mL) presented in a single-dose glass vial. REVATIO Injection Package Configuration Strength NDC Vial individually packaged in a carton 10 mg/12.5 mL (0.8 mg/mL) 58151-395-31 Recommended Storage for REVATIO Injection: Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Discard unused portion. REVATIO powder for oral suspension is supplied in amber glass bottles. Each bottle contains white to slight pink powder containing 1.57 g of sildenafil citrate (equivalent to 1.12 g sildenafil). Following reconstitution, the total volume of the oral suspension is 112 mL (10 mg sildenafil/mL). A 2 mL oral dosing syringe (with 1 mL and 2 mL dose markings) and a press-in bottle adaptor are also provided. REVATIO Powder for Oral Suspension Package Configuration Strength NDC Powder for oral suspension - bottle 10 mg/mL (when reconstituted) 58151-385-35 Recommended Storage for REVATIO for Oral Suspension: Store below 30°C (86°F) in the original package in order to protect from moisture. Recommended Storage for Reconstituted Oral Suspension: Store below 30°C (86°F) or in refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. The shelf-life of the reconstituted oral suspension is 60 days. Any remaining oral suspension should be discarded 60 days after reconstitution.
- PRINCIPAL DISPLAY PANEL – 20 mg NDC 58151-402-77 Revatio ® (sildenafil) tablets 20 mg* Rx only 90 Tablets Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Dispense in tight containers (USP). DOSAGE AND USE See accompanying prescribing information. *Each tablet contains sildenafil citrate equivalent to 20 mg sildenafil. Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. © 2024 Viatris Inc. Made in France RUPJ402MM Bottle Label Revatio 20 mg
- PRINCIPAL DISPLAY PANEL – 10 mg/12.5 mL NDC 58151-395-31 Sterile Single-dose Vial Rx only Revatio ® (sildenafil) Injection 10 mg/12.5 mL (0.8 mg/mL) For Intravenous Use Sterile Single-dose Vial, Discard Unused Portion Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Each mL of solution contains 1.124 mg sildenafil citrate, 50.5 mg dextrose and Water for Injection. DOSAGE AND USE See accompanying prescribing information. Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. © 2024 Viatris Inc. REVATIO is a registered trademark of Viatris Specialty LLC, a Viatris Company. Made in France UPJ:395:1C:R1 Carton Label Revatio 10 mg/12.5 mL
- PRINCIPAL DISPLAY PANEL – 10 mg/mL NDC 58151-385-35 Rx only Revatio® (sildenafil) for oral suspension 10 mg/mL For Oral Use Only Shake Well Before Each Use RECONSTITUTION DIRECTIONS: Gently tap the bottle to loosen the powder. The total volume of water to be added is 90 mL. Add 60 mL of water and shake vigorously for at least 30 seconds. Add another 30 mL of water and shake for at least another 30 seconds to obtain a uniform suspension. 112 mL following Reconstitution Grape Flavored Rx only BEFORE RECONSTITUTION: Recommended storage for Revatio powder for oral suspension: Store below 30°C (86°F) in the original package in order to protect from moisture. RECONSTITUTED SUSPENSION: Store below 30°C (86°F) or in refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Discard any unused portion 60 days after reconstitution. Each mL of the suspension contains 10 mg of sildenafil (as citrate) when reconstituted with 90 mL water. Each bottle contains 1.57 g of sildenafil citrate (1.12 g sildenafil). RECOMMENDED DOSAGE: See prescribing information. An oral dosing syringe, and a press-in bottle adaptor are also provided. Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. © 2024 Viatris Inc. REVATIO is a registered trademark of Viatris Specialty LLC, a Viatris Company. Made in France UPJ:385:1C:R1 Carton Label Revatio 10 mg/mL
Packages (0)
No package records.
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
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