FDA.reportPublic FDA data

Sildenafil

Product NDC
50090-7963
11-digit product format
500907963
Labeler code
50090
Product ID
50090-7963_08cdf83e-2b2e-4d8a-9b78-76f42cee61c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203962
Marketing category
ANDA
Marketing start
2018-06-11
Substance
SILDENAFIL CITRATE
Active strength
25 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
Sildenafil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui314228

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
50090-7963-0Sildenafil10 in 1 BOTTLETABLET, FILM COATED103

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314228sildenafil citrate 25 MG Oral TabletPSNa10b7ec1-bb59-4906-b32d-fbd2a17ed7a83
314228sildenafil 25 MG Oral TabletSCDa10b7ec1-bb59-4906-b32d-fbd2a17ed7a83
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSYa10b7ec1-bb59-4906-b32d-fbd2a17ed7a83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7963-05009079630010 TABLET, FILM COATED in 1 BOTTLE (50090-7963-0) 2026-05-13NoNoCurrent