Sildenafil

Product NDC
72865-105
11-digit product format
728650105
Labeler code
72865
Product ID
72865-105_f26fd814-a6cb-4749-e053-2a95a90a26fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
XLCare Pharmaceuticals, Inc.
Application
ANDA203623
Marketing category
ANDA
Marketing start
2019-07-10
Substance
SILDENAFIL CITRATE
Active strength
20 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 CITRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui577033

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
72865-105-90Sildenafil90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-105SILDENAFIL TABLET, FILM COATED [XLCARE PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 1 package rows20230117_22d70b8d-41bc-416d-89e9-e4c39db0af83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN22d70b8d-41bc-416d-89e9-e4c39db0af832
577033sildenafil 20 MG Oral TabletSCD22d70b8d-41bc-416d-89e9-e4c39db0af832
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY22d70b8d-41bc-416d-89e9-e4c39db0af832

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72865-105-907286501059090 TABLET, FILM COATED in 1 BOTTLE (72865-105-90) 2019-07-100000-00-00NoNoCurrent