SILDENAFIL

Product NDC
72189-069
11-digit product format
721890069
Labeler code
72189
Product ID
72189-069_2be7ed74-ac68-c313-e063-6294a90ad14c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA202659
Marketing category
ANDA
Marketing start
2020-06-17
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
72189-069-10SILDENAFIL10 in 1 BOTTLETABLET, FILM COATED104
72189-069-30SILDENAFIL30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-069SILDENAFIL TABLET, FILM COATED [DIRECT RX]4Current NDC, Legacy NDC, 2 package rows20250119_a84a418a-155c-7be7-e053-2995a90a8158.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNa84a418a-155c-7be7-e053-2995a90a81584
314229sildenafil 100 MG Oral TabletSCDa84a418a-155c-7be7-e053-2995a90a81584
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYa84a418a-155c-7be7-e053-2995a90a81584

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-069-107218900691010 TABLET, FILM COATED in 1 BOTTLE (72189-069-10) 2020-06-170000-00-00NoNoCurrent
72189-069-307218900693030 TABLET, FILM COATED in 1 BOTTLE (72189-069-30) 2020-06-170000-00-00NoNoCurrent