FDA.reportPublic FDA data

Revatio

Product NDC
58151-395
11-digit product format
581510395
Labeler code
58151
Product ID
58151-395_3fa2b889-ff04-4db1-b2c8-c0238efe240b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sildenafil citrate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Viatris Specialty LLC
Application
NDA022473
Marketing category
NDA
Marketing start
2025-04-09
Substance
SILDENAFIL CITRATE
Active strength
.8 mg/mL
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Revatio
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE.8 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui577033, 581645, 882527, 882530, 1307427, 1307431

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fabccea2-36c8-9268-ee44-ec231455538fProduct name920241217
ac996ae9-22a2-41c2-bb86-913c4aef95adProduct name120230606
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
fc95c9f0-00dc-40ef-bcea-b60c9009c5fcProduct name920220613
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58151-395-31Revatio12.5 mL in 1 VIALINJECTION, SOLUTION12.54
58151-395-31Revatio1 in 1 CARTONINJECTION, SOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58151-395-31ML - Milliliter58151-395a5a4e976-16ec-40de-a4c8-5cddb67364d612025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-395REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [VIATRIS SPECIALTY LLC]3Current NDC, 2 package rows20250410_3bb9363e-b28d-4019-8aae-539233dca214.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1307431Revatio 10 MG in 1 mL Oral SuspensionPSN3bb9363e-b28d-4019-8aae-539233dca2144
882530Revatio 10 MG in 12.5 ML InjectionPSN3bb9363e-b28d-4019-8aae-539233dca2144
581645Revatio 20 MG Oral TabletPSN3bb9363e-b28d-4019-8aae-539233dca2144
1307427sildenafil 10 MG in 1 mL Oral SuspensionPSN3bb9363e-b28d-4019-8aae-539233dca2144
882527sildenafil 10 MG in 12.5 ML InjectionPSN3bb9363e-b28d-4019-8aae-539233dca2144
577033sildenafil citrate 20 MG Oral TabletPSN3bb9363e-b28d-4019-8aae-539233dca2144
88253012.5 ML sildenafil 0.8 MG/ML Injection [Revatio]SBD3bb9363e-b28d-4019-8aae-539233dca2144
1307431sildenafil 10 MG/ML Oral Suspension [Revatio]SBD3bb9363e-b28d-4019-8aae-539233dca2144
581645sildenafil 20 MG Oral Tablet [Revatio]SBD3bb9363e-b28d-4019-8aae-539233dca2144
88252712.5 ML sildenafil 0.8 MG/ML InjectionSCD3bb9363e-b28d-4019-8aae-539233dca2144
1307427sildenafil 10 MG/ML Oral SuspensionSCD3bb9363e-b28d-4019-8aae-539233dca2144
577033sildenafil 20 MG Oral TabletSCD3bb9363e-b28d-4019-8aae-539233dca2144
88253012.5 ML Revatio 0.8 MG/ML InjectionSY3bb9363e-b28d-4019-8aae-539233dca2144
882530Revatio (as sildenafil citrate) 10 MG per 12.5 ML InjectionSY3bb9363e-b28d-4019-8aae-539233dca2144
1307431Revatio (as sildenafil citrate) 10 MG/ML Powder for Oral SuspensionSY3bb9363e-b28d-4019-8aae-539233dca2144
1307431Revatio 10 MG per 1 ML Oral SuspensionSY3bb9363e-b28d-4019-8aae-539233dca2144
1307431Revatio 10 MG/ML Oral SuspensionSY3bb9363e-b28d-4019-8aae-539233dca2144
581645Revatio 20 MG (as sildenafil citrate) Oral TabletSY3bb9363e-b28d-4019-8aae-539233dca2144
581645Revatio 20 MG Oral TabletSY3bb9363e-b28d-4019-8aae-539233dca2144
882527sildenafil (as sildenafil citrate) 10 MG per 12.5 ML InjectionSY3bb9363e-b28d-4019-8aae-539233dca2144
1307427sildenafil (as sildenafil citrate) 10 MG/ML Powder for Oral SuspensionSY3bb9363e-b28d-4019-8aae-539233dca2144
1307427sildenafil 10 MG per 1 ML Oral SuspensionSY3bb9363e-b28d-4019-8aae-539233dca2144
882527sildenafil 10 MG per 12.5 ML InjectionSY3bb9363e-b28d-4019-8aae-539233dca2144
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY3bb9363e-b28d-4019-8aae-539233dca2144

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58151-395-31581510395311 VIAL in 1 CARTON (58151-395-31) / 12.5 mL in 1 VIAL1 vial2025-04-09NoNoCurrent