FDA.reportPublic FDA data

Sildenafil

Product NDC
35561-253
11-digit product format
355610253
Labeler code
35561
Product ID
35561-253_49fc9324-58cc-2875-e063-6394a90a5363
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bostal LLC
Application
ANDA208494
Marketing category
ANDA
Marketing start
2020-04-22
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
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 CITRATE100 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
35561-253-102026-01-29C16284748780-149896155-bf62-586f-e063-e6dba90add90These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
35561-253-142026-01-29C16284748780-149896155-bf62-586f-e063-e6dba90add90These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35561-253-10Sildenafil30 in 1 BOTTLETABLET, FILM COATED306
35561-253-14Sildenafil1000 in 1 BOTTLETABLET, FILM COATED10006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35561-253SILDENAFIL TABLET, FILM COATED [AUSTARPHARMA LLC]5Current NDC, Legacy NDC, 2 package rows20240410_428bbcff-0faf-499c-81b2-6ac76c0687c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN428bbcff-0faf-499c-81b2-6ac76c0687c06
314228sildenafil citrate 25 MG Oral TabletPSN428bbcff-0faf-499c-81b2-6ac76c0687c06
312950sildenafil citrate 50 MG Oral TabletPSN428bbcff-0faf-499c-81b2-6ac76c0687c06
314229sildenafil 100 MG Oral TabletSCD428bbcff-0faf-499c-81b2-6ac76c0687c06
314228sildenafil 25 MG Oral TabletSCD428bbcff-0faf-499c-81b2-6ac76c0687c06
312950sildenafil 50 MG Oral TabletSCD428bbcff-0faf-499c-81b2-6ac76c0687c06
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY428bbcff-0faf-499c-81b2-6ac76c0687c06
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY428bbcff-0faf-499c-81b2-6ac76c0687c06
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY428bbcff-0faf-499c-81b2-6ac76c0687c06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
35561-253-103556102531030 TABLET, FILM COATED in 1 BOTTLE (35561-253-10) 2020-04-220000-00-00NoNoCurrent
35561-253-14355610253141000 TABLET, FILM COATED in 1 BOTTLE (35561-253-14) 2020-04-220000-00-00NoNoCurrent