Sildenafil

Product NDC
71209-106
11-digit product format
712090106
Labeler code
71209
Product ID
71209-106_eff134c4-3240-4132-b9ea-118ce1fa719a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cadila Pharmaceuticals Limited
Application
ANDA218045
Marketing category
ANDA
Marketing start
2023-12-01
Substance
SILDENAFIL CITRATE
Active strength
25 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 CITRATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui312950, 314228, 314229

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
71209-106-01Sildenafil30 in 1 BOTTLETABLET, FILM COATED304
71209-106-05Sildenafil100 in 1 BOTTLETABLET, FILM COATED1004
71209-106-11Sildenafil1000 in 1 BOTTLETABLET, FILM COATED10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71209-106SILDENAFIL TABLET, FILM COATED [CADILA PHARMACEUTICALS LIMITED]4Current NDC, 3 package rows20250214_c079fc41-7b9a-499d-88ea-86ccb65c828d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNc079fc41-7b9a-499d-88ea-86ccb65c828d4
314228sildenafil citrate 25 MG Oral TabletPSNc079fc41-7b9a-499d-88ea-86ccb65c828d4
312950sildenafil citrate 50 MG Oral TabletPSNc079fc41-7b9a-499d-88ea-86ccb65c828d4
314229sildenafil 100 MG Oral TabletSCDc079fc41-7b9a-499d-88ea-86ccb65c828d4
314228sildenafil 25 MG Oral TabletSCDc079fc41-7b9a-499d-88ea-86ccb65c828d4
312950sildenafil 50 MG Oral TabletSCDc079fc41-7b9a-499d-88ea-86ccb65c828d4
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYc079fc41-7b9a-499d-88ea-86ccb65c828d4
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSYc079fc41-7b9a-499d-88ea-86ccb65c828d4
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYc079fc41-7b9a-499d-88ea-86ccb65c828d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71209-106-017120901060130 TABLET, FILM COATED in 1 BOTTLE (71209-106-01) 2023-12-01NoNoCurrent
71209-106-0571209010605100 TABLET, FILM COATED in 1 BOTTLE (71209-106-05) 2023-12-01NoNoCurrent
71209-106-11712090106111000 TABLET, FILM COATED in 1 BOTTLE (71209-106-11) 2023-12-01NoNoCurrent