Sildenafil

Product NDC
72789-103
11-digit product format
727890103
Labeler code
72789
Product ID
72789-103_4c4e9d24-ee4e-509d-e063-6394a90acedb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA202659
Marketing category
ANDA
Marketing start
2018-06-11
Substance
SILDENAFIL CITRATE
Active strength
50 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sildenafil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui312950

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
72789-103-15Sildenafil15 in 1 BOTTLE, PLASTICTABLET, FILM COATED159
72789-103-90Sildenafil90 in 1 BOTTLE, PLASTICTABLET, FILM COATED909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-103SILDENAFIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 2 package rows20241010_4e3034af-bee5-4df4-8beb-fbd2b510ad73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312950sildenafil citrate 50 MG Oral TabletPSN4e3034af-bee5-4df4-8beb-fbd2b510ad739
312950sildenafil 50 MG Oral TabletSCD4e3034af-bee5-4df4-8beb-fbd2b510ad739
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY4e3034af-bee5-4df4-8beb-fbd2b510ad739

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-103-157278901031515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-103-15) 2020-07-220000-00-00NoNoCurrent
72789-103-907278901039090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-103-90) 2026-03-05NoNoCurrent