FDA.reportPublic FDA data

Viagra

Product NDC
50090-0619
11-digit product format
500900619
Labeler code
50090
Product ID
50090-0619_59b422e0-2b24-46b7-adef-50a7d14a1e6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sildenafil citrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA020895
Marketing category
NDA
Marketing start
1998-03-27
Marketing end
0000-00-00
Substance
SILDENAFIL CITRATE
Active strength
100 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0619-82023-01-30C16284748780-1f386c649-c4dc-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VIAGRA safely and effectively. See full prescribing information for VIAGRA. VIAGRA® (sildenafil citrate) tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0619-8Viagra4 in 1 BOTTLETABLET, FILM COATED47

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0619VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]7Legacy NDC, 1 package rows20200121_ae2079a2-f3a9-4739-9611-0742b71e4761.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNae2079a2-f3a9-4739-9611-0742b71e47617
213271Viagra 100 MG Oral TabletPSNae2079a2-f3a9-4739-9611-0742b71e47617
213271sildenafil 100 MG Oral Tablet [Viagra]SBDae2079a2-f3a9-4739-9611-0742b71e47617
314229sildenafil 100 MG Oral TabletSCDae2079a2-f3a9-4739-9611-0742b71e47617
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYae2079a2-f3a9-4739-9611-0742b71e47617
213271Viagra 100 MG (as sildenafil citrate) Oral TabletSYae2079a2-f3a9-4739-9611-0742b71e47617
213271Viagra 100 MG Oral TabletSYae2079a2-f3a9-4739-9611-0742b71e47617

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0619-8500900619084 TABLET, FILM COATED in 1 BOTTLE (50090-0619-8) 2014-11-280000-00-00NoNoCurrent