FDA.reportPublic FDA data

Revatio

Product NDC
0069-4190
11-digit product format
000694190
Labeler code
0069
Product ID
0069-4190_92557457-d941-4560-bfb1-1284d8902907
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sildenafil citrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PFIZER LABORATORIES DIV PFIZER INC
Application
NDA021845
Marketing category
NDA
Marketing start
2005-06-03
Substance
SILDENAFIL CITRATE
Active strength
20 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fabccea2-36c8-9268-ee44-ec231455538fProduct name920241217
ac996ae9-22a2-41c2-bb86-913c4aef95adProduct name120230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fcProduct name920220613

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-4190-68Revatio90 in 1 BOTTLETABLET, FILM COATED9045

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-4190-68EA - Each0069-41905343a4f6-b5af-44ba-adbf-56ac817e57a412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SILDENAFIL CITRATEACTIVE INGREDIENTBW9B0ZE037REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]33
SILDENAFILACTIVE MOIETY3M7OB98Y7HREVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]33
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLREVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]33
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JREVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]33
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UREVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]33
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]33
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]33
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOREVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]33
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XREVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]33
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]33
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]33
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUREVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]33
SORBITOLINACTIVE INGREDIENT506T60A25RREVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]33
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]33
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPREVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]33
TRIACETININACTIVE INGREDIENTXHX3C3X673REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]33
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KREVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]33
WATERINACTIVE INGREDIENT059QF0KO0RREVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]33
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEREVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-4190REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]44Current NDC, Legacy NDC, 1 package rows20250410_f158fe10-d5dc-4432-b2c9-fc665401291b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1307431Revatio 10 MG in 1 mL Oral SuspensionPSNf158fe10-d5dc-4432-b2c9-fc665401291b45
882530Revatio 10 MG in 12.5 ML InjectionPSNf158fe10-d5dc-4432-b2c9-fc665401291b45
581645Revatio 20 MG Oral TabletPSNf158fe10-d5dc-4432-b2c9-fc665401291b45
1307427sildenafil 10 MG in 1 mL Oral SuspensionPSNf158fe10-d5dc-4432-b2c9-fc665401291b45
882527sildenafil 10 MG in 12.5 ML InjectionPSNf158fe10-d5dc-4432-b2c9-fc665401291b45
577033sildenafil citrate 20 MG Oral TabletPSNf158fe10-d5dc-4432-b2c9-fc665401291b45
88253012.5 ML sildenafil 0.8 MG/ML Injection [Revatio]SBDf158fe10-d5dc-4432-b2c9-fc665401291b45
1307431sildenafil 10 MG/ML Oral Suspension [Revatio]SBDf158fe10-d5dc-4432-b2c9-fc665401291b45
581645sildenafil 20 MG Oral Tablet [Revatio]SBDf158fe10-d5dc-4432-b2c9-fc665401291b45
88252712.5 ML sildenafil 0.8 MG/ML InjectionSCDf158fe10-d5dc-4432-b2c9-fc665401291b45
1307427sildenafil 10 MG/ML Oral SuspensionSCDf158fe10-d5dc-4432-b2c9-fc665401291b45
577033sildenafil 20 MG Oral TabletSCDf158fe10-d5dc-4432-b2c9-fc665401291b45
88253012.5 ML Revatio 0.8 MG/ML InjectionSYf158fe10-d5dc-4432-b2c9-fc665401291b45
882530Revatio (as sildenafil citrate) 10 MG per 12.5 ML InjectionSYf158fe10-d5dc-4432-b2c9-fc665401291b45
1307431Revatio (as sildenafil citrate) 10 MG/ML Powder for Oral SuspensionSYf158fe10-d5dc-4432-b2c9-fc665401291b45
1307431Revatio 10 MG per 1 ML Oral SuspensionSYf158fe10-d5dc-4432-b2c9-fc665401291b45
1307431Revatio 10 MG/ML Oral SuspensionSYf158fe10-d5dc-4432-b2c9-fc665401291b45
581645Revatio 20 MG (as sildenafil citrate) Oral TabletSYf158fe10-d5dc-4432-b2c9-fc665401291b45
581645Revatio 20 MG Oral TabletSYf158fe10-d5dc-4432-b2c9-fc665401291b45
882527sildenafil (as sildenafil citrate) 10 MG per 12.5 ML InjectionSYf158fe10-d5dc-4432-b2c9-fc665401291b45
1307427sildenafil (as sildenafil citrate) 10 MG/ML Powder for Oral SuspensionSYf158fe10-d5dc-4432-b2c9-fc665401291b45
1307427sildenafil 10 MG per 1 ML Oral SuspensionSYf158fe10-d5dc-4432-b2c9-fc665401291b45
882527sildenafil 10 MG per 12.5 ML InjectionSYf158fe10-d5dc-4432-b2c9-fc665401291b45
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYf158fe10-d5dc-4432-b2c9-fc665401291b45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0069-4190-680006941906890 TABLET, FILM COATED in 1 BOTTLE (0069-4190-68) 2005-06-030000-00-00NoNoCurrent