FDA.reportPublic FDA data

Sildenafil

Product NDC
72865-103
11-digit product format
728650103
Labeler code
72865
Product ID
72865-103_f26fd1e1-7c9e-b45b-e053-2995a90a162d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
XLCARE Pharmaceuticals INC.
Application
ANDA202659
Marketing category
ANDA
Marketing start
2019-08-01
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
Rxcui312950, 314228, 314229

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
72865-103-01Sildenafil100 in 1 BOTTLETABLET, FILM COATED1002
72865-103-30Sildenafil30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-103SILDENAFIL (SILDENAFIL) TABLET, FILM COATED [XLCARE PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 2 package rows20230117_ae732301-384f-43ae-80d1-5e3784fe1dca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNae732301-384f-43ae-80d1-5e3784fe1dca2
314228sildenafil citrate 25 MG Oral TabletPSNae732301-384f-43ae-80d1-5e3784fe1dca2
312950sildenafil citrate 50 MG Oral TabletPSNae732301-384f-43ae-80d1-5e3784fe1dca2
314229sildenafil 100 MG Oral TabletSCDae732301-384f-43ae-80d1-5e3784fe1dca2
314228sildenafil 25 MG Oral TabletSCDae732301-384f-43ae-80d1-5e3784fe1dca2
312950sildenafil 50 MG Oral TabletSCDae732301-384f-43ae-80d1-5e3784fe1dca2
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYae732301-384f-43ae-80d1-5e3784fe1dca2
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSYae732301-384f-43ae-80d1-5e3784fe1dca2
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYae732301-384f-43ae-80d1-5e3784fe1dca2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72865-103-0172865010301100 TABLET, FILM COATED in 1 BOTTLE (72865-103-01) 2019-08-010000-00-00NoNoCurrent
72865-103-307286501033030 TABLET, FILM COATED in 1 BOTTLE (72865-103-30) 2019-08-010000-00-00NoNoCurrent