SILDENAFIL CITRATE

Product NDC
72603-883
11-digit product format
726030883
Labeler code
72603
Product ID
72603-883_4bb9baea-3bd6-03c0-e063-6294a90a218a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL CITRATE
Dosage form
TABLET
Route
ORAL
Labeler
Northstar Rx LLC
Application
ANDA209302
Marketing category
ANDA
Marketing start
2026-02-24
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
72603-883-01SILDENAFIL CITRATE30 in 1 BOTTLETABLET301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN8127ff38-2761-49ec-8ce7-7f971f521cfb1
314228sildenafil citrate 25 MG Oral TabletPSN8127ff38-2761-49ec-8ce7-7f971f521cfb1
312950sildenafil citrate 50 MG Oral TabletPSN8127ff38-2761-49ec-8ce7-7f971f521cfb1
314229sildenafil 100 MG Oral TabletSCD8127ff38-2761-49ec-8ce7-7f971f521cfb1
314228sildenafil 25 MG Oral TabletSCD8127ff38-2761-49ec-8ce7-7f971f521cfb1
312950sildenafil 50 MG Oral TabletSCD8127ff38-2761-49ec-8ce7-7f971f521cfb1
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY8127ff38-2761-49ec-8ce7-7f971f521cfb1
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY8127ff38-2761-49ec-8ce7-7f971f521cfb1
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY8127ff38-2761-49ec-8ce7-7f971f521cfb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-883-017260308830130 TABLET in 1 BOTTLE (72603-883-01) 30 tablet2026-02-24NoNoCurrent