FDA.reportPublic FDA data

Sildenafil

Product NDC
50090-5235
11-digit product format
500905235
Labeler code
50090
Product ID
50090-5235_893aeefd-b757-4d8c-8f17-711a114c0d9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202659
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5235-02023-05-23C16284748780-1f386c64a-01c6-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
50090-5235-02023-01-30C16284748780-1f386c64a-01c6-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5235-0Sildenafil10 in 1 BOTTLETABLET, FILM COATED104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5235SILDENAFIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 1 package rows20230524_3145ceda-8c1e-4601-8a9d-5fc4978226d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314228sildenafil citrate 25 MG Oral TabletPSN3145ceda-8c1e-4601-8a9d-5fc4978226d64
314228sildenafil 25 MG Oral TabletSCD3145ceda-8c1e-4601-8a9d-5fc4978226d64
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY3145ceda-8c1e-4601-8a9d-5fc4978226d64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5235-05009052350010 TABLET, FILM COATED in 1 BOTTLE (50090-5235-0) 2020-10-090000-00-00NoNoCurrent