FDA.reportPublic FDA data

SILDENAFIL

Product NDC
72189-298
11-digit product format
721890298
Labeler code
72189
Product ID
72189-298_2c294bda-345a-ad0e-e063-6294a90a0304
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL
Dosage form
TABLET
Route
ORAL
Labeler
DirectRx
Application
ANDA210394
Marketing category
ANDA
Marketing start
2021-11-29
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
72189-298-15SILDENAFIL15 in 1 BOTTLETABLET156
72189-298-20SILDENAFIL20 in 1 BOTTLETABLET206
72189-298-30SILDENAFIL30 in 1 BOTTLETABLET306
72189-298-90SILDENAFIL90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-298SILDENAFIL TABLET [DIRECTRX]6Current NDC, Legacy NDC, 4 package rows20250121_d1ee9139-13ac-7d5b-e053-2995a90a8e50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNd1ee9139-13ac-7d5b-e053-2995a90a8e506
577033sildenafil 20 MG Oral TabletSCDd1ee9139-13ac-7d5b-e053-2995a90a8e506
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYd1ee9139-13ac-7d5b-e053-2995a90a8e506

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-298-157218902981515 TABLET in 1 BOTTLE (72189-298-15) 15 tablet2021-11-29NoNoCurrent
72189-298-207218902982020 TABLET in 1 BOTTLE (72189-298-20) 20 tablet2021-11-290000-00-00NoNoCurrent
72189-298-307218902983030 TABLET in 1 BOTTLE (72189-298-30) 30 tablet2022-07-280000-00-00NoNoCurrent
72189-298-907218902989090 TABLET in 1 BOTTLE (72189-298-90) 90 tablet2021-11-290000-00-00NoNoCurrent