FDA.reportPublic FDA data

Sildenafil

Product NDC
72789-098
11-digit product format
727890098
Labeler code
72789
Product ID
72789-098_4031d438-4491-8f2e-e063-6394a90a9510
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
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
72789-098-10Sildenafil10 in 1 BOTTLE, PLASTICTABLET, FILM COATED109
72789-098-15Sildenafil15 in 1 BOTTLE, PLASTICTABLET, FILM COATED159
72789-098-90Sildenafil90 in 1 BOTTLE, PLASTICTABLET, FILM COATED909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-098SILDENAFIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 3 package rows20240522_e1af7b6a-378e-4337-858f-85a926eec102.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNe1af7b6a-378e-4337-858f-85a926eec1029
314229sildenafil 100 MG Oral TabletSCDe1af7b6a-378e-4337-858f-85a926eec1029
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYe1af7b6a-378e-4337-858f-85a926eec1029

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-098-107278900981010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-098-10) 2020-07-150000-00-00NoNoCurrent
72789-098-157278900981515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-098-15) 2020-08-040000-00-00NoNoCurrent
72789-098-907278900989090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-098-90) 2024-05-21NoNoCurrent