FDA.reportPublic FDA data

Sildenafil

Product NDC
50090-5415
11-digit product format
500905415
Labeler code
50090
Product ID
50090-5415_13483d93-57aa-42a6-86ea-ad308c07321a
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
50 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 CITRATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui312950

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
50090-5415-02023-02-07C16284748780-1f386c64a-1785-0266-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
50090-5415-02023-01-30C16284748780-1f386c64a-1785-0266-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
50090-5415-0Sildenafil10 in 1 BOTTLETABLET, FILM COATED108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5415-0EA - Each50090-5415b8582aac-cbdf-4c8d-a3cd-586f1cd76d0612023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5415SILDENAFIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 1 package rows20230729_997197bf-7706-4e12-97df-b0a9ea6d3a10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312950sildenafil citrate 50 MG Oral TabletPSN997197bf-7706-4e12-97df-b0a9ea6d3a108
312950sildenafil 50 MG Oral TabletSCD997197bf-7706-4e12-97df-b0a9ea6d3a108
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY997197bf-7706-4e12-97df-b0a9ea6d3a108

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5415-05009054150010 TABLET, FILM COATED in 1 BOTTLE (50090-5415-0) 2020-12-220000-00-00NoNoCurrent