FDA.reportPublic FDA data

Viagra

Product NDC
58151-427
11-digit product format
581510427
Labeler code
58151
Product ID
58151-427_dcf22623-9736-40dd-8313-394101f02fdc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sildenafil citrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Viatris Specialty LLC
Application
NDA020895
Marketing category
NDA
Marketing start
2025-08-05
Substance
SILDENAFIL CITRATE
Active strength
50 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Viagra
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui213269, 213270, 213271, 312950, 314228, 314229

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
58151-427-01Viagra100 in 1 BOTTLETABLET, FILM COATED1006
58151-427-93Viagra30 in 1 BOTTLETABLET, FILM COATED306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58151-427-01EA - Each58151-4279c2bdbc7-6f45-48e4-9439-4ce772a9126012025-09-12
58151-427-93EA - Each58151-42722747ff8-8bd6-4272-b825-e03c0811e16612026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-427VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [VIATRIS SPECIALTY LLC]2Current NDC, 2 package rows20250406_d905dc8d-917f-4ea3-a4ee-a1ecf6967d4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNd905dc8d-917f-4ea3-a4ee-a1ecf6967d4e6
314228sildenafil citrate 25 MG Oral TabletPSNd905dc8d-917f-4ea3-a4ee-a1ecf6967d4e6
312950sildenafil citrate 50 MG Oral TabletPSNd905dc8d-917f-4ea3-a4ee-a1ecf6967d4e6
213271Viagra 100 MG Oral TabletPSNd905dc8d-917f-4ea3-a4ee-a1ecf6967d4e6
213269Viagra 25 MG Oral TabletPSNd905dc8d-917f-4ea3-a4ee-a1ecf6967d4e6
213270Viagra 50 MG Oral TabletPSNd905dc8d-917f-4ea3-a4ee-a1ecf6967d4e6
213271sildenafil 100 MG Oral Tablet [Viagra]SBDd905dc8d-917f-4ea3-a4ee-a1ecf6967d4e6
213269sildenafil 25 MG Oral Tablet [Viagra]SBDd905dc8d-917f-4ea3-a4ee-a1ecf6967d4e6
213270sildenafil 50 MG Oral Tablet [Viagra]SBDd905dc8d-917f-4ea3-a4ee-a1ecf6967d4e6
314229sildenafil 100 MG Oral TabletSCDd905dc8d-917f-4ea3-a4ee-a1ecf6967d4e6
314228sildenafil 25 MG Oral TabletSCDd905dc8d-917f-4ea3-a4ee-a1ecf6967d4e6
312950sildenafil 50 MG Oral TabletSCDd905dc8d-917f-4ea3-a4ee-a1ecf6967d4e6
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYd905dc8d-917f-4ea3-a4ee-a1ecf6967d4e6
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSYd905dc8d-917f-4ea3-a4ee-a1ecf6967d4e6
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYd905dc8d-917f-4ea3-a4ee-a1ecf6967d4e6
213271Viagra 100 MG (as sildenafil citrate) Oral TabletSYd905dc8d-917f-4ea3-a4ee-a1ecf6967d4e6
213271Viagra 100 MG Oral TabletSYd905dc8d-917f-4ea3-a4ee-a1ecf6967d4e6
213269Viagra 25 MG (as sildenafil citrate) Oral TabletSYd905dc8d-917f-4ea3-a4ee-a1ecf6967d4e6
213269Viagra 25 MG Oral TabletSYd905dc8d-917f-4ea3-a4ee-a1ecf6967d4e6
213270Viagra 50 MG (as sildenafil citrate) Oral TabletSYd905dc8d-917f-4ea3-a4ee-a1ecf6967d4e6
213270Viagra 50 MG Oral TabletSYd905dc8d-917f-4ea3-a4ee-a1ecf6967d4e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
58151-427-0158151042701100 TABLET, FILM COATED in 1 BOTTLE (58151-427-01) 2025-08-05NoNoCurrent
58151-427-935815104279330 TABLET, FILM COATED in 1 BOTTLE (58151-427-93) 2026-02-11NoNoCurrent