Sildenafil

Product NDC
50090-5325
11-digit product format
500905325
Labeler code
50090
Product ID
50090-5325_f68bfe89-9f78-498b-828d-4ea58c4af9bf
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
100 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 CITRATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui314229

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
50090-5325-0Sildenafil10 in 1 BOTTLETABLET, FILM COATED106
50090-5325-1Sildenafil30 in 1 BOTTLETABLET, FILM COATED306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5325-0EA - Each50090-532544bbe6e3-4eda-4b83-9fac-886b17546e3b12022-10-06
50090-5325-1EA - Each50090-53251d9135c0-1810-41cf-a9d3-17dcf1fca16812022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5325SILDENAFIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20231109_eaeab74e-38cc-4621-9ce8-8a5d74a29a9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNeaeab74e-38cc-4621-9ce8-8a5d74a29a9e6
314229sildenafil 100 MG Oral TabletSCDeaeab74e-38cc-4621-9ce8-8a5d74a29a9e6
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYeaeab74e-38cc-4621-9ce8-8a5d74a29a9e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5325-05009053250010 TABLET, FILM COATED in 1 BOTTLE (50090-5325-0) 2020-10-300000-00-00NoNoCurrent
50090-5325-15009053250130 TABLET, FILM COATED in 1 BOTTLE (50090-5325-1) 2020-10-300000-00-00NoNoCurrent