FDA.reportPublic FDA data

SILDENAFIL CITRATE

Product NDC
72789-406
11-digit product format
727890406
Labeler code
72789
Product ID
72789-406_31f7b5b5-476d-0490-e063-6394a90a88f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL CITRATE
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA209302
Marketing category
ANDA
Marketing start
2020-09-04
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 CITRATE
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
72789-406-15SILDENAFIL CITRATE15 in 1 BOTTLE, PLASTICTABLET1512
72789-406-30SILDENAFIL CITRATE30 in 1 BOTTLE, PLASTICTABLET3012
72789-406-90SILDENAFIL CITRATE90 in 1 BOTTLE, PLASTICTABLET9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-406-15EA - Each72789-4066c3bf0c1-9b2b-446e-bfb1-75a4a9ae486012024-10-04
72789-406-30EA - Each72789-406f24d974b-d71d-4dec-8f76-9e791674da5612024-10-04
72789-406-90EA - Each72789-40666dab48c-3439-4b7e-b194-5d9e9584ed3d12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-406SILDENAFIL CITRATE TABLET [PD-RX PHARMACEUTICALS, INC.]12Current NDC, 3 package rows20250406_f1122baa-8dee-43fc-bd3d-501a55b696b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNf1122baa-8dee-43fc-bd3d-501a55b696b312
314229sildenafil 100 MG Oral TabletSCDf1122baa-8dee-43fc-bd3d-501a55b696b312
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYf1122baa-8dee-43fc-bd3d-501a55b696b312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-406-157278904061515 TABLET in 1 BOTTLE, PLASTIC (72789-406-15) 15 tablet2024-06-07NoNoCurrent
72789-406-307278904063030 TABLET in 1 BOTTLE, PLASTIC (72789-406-30) 30 tablet2024-06-07NoNoCurrent
72789-406-907278904069090 TABLET in 1 BOTTLE, PLASTIC (72789-406-90) 90 tablet2024-06-07NoNoCurrent