FDA.reportPublic FDA data

Sildenafil

Product NDC
71335-0969
11-digit product format
713350969
Labeler code
71335
Product ID
71335-0969_d1050818-e0b0-4be8-88c3-80e4a20e5250
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202023
Marketing category
ANDA
Marketing start
2018-06-28
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0969-02024-05-17C16284748780-11030e365-0f37-111a-e063-dadaa90a10e2These 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
71335-0969-12024-05-17C16284748780-11030e365-0f37-111a-e063-dadaa90a10e2These 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
71335-0969-22024-05-17C16284748780-11030e365-0f37-111a-e063-dadaa90a10e2These 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
71335-0969-32024-05-17C16284748780-11030e365-0f37-111a-e063-dadaa90a10e2These 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
71335-0969-42024-05-17C16284748780-11030e365-0f37-111a-e063-dadaa90a10e2These 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
71335-0969-52024-05-17C16284748780-11030e365-0f37-111a-e063-dadaa90a10e2These 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
71335-0969-62024-05-17C16284748780-11030e365-0f37-111a-e063-dadaa90a10e2These 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
71335-0969-72024-05-17C16284748780-11030e365-0f37-111a-e063-dadaa90a10e2These 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
71335-0969-82024-05-17C16284748780-11030e365-0f37-111a-e063-dadaa90a10e2These 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
71335-0969-92024-05-17C16284748780-11030e365-0f37-111a-e063-dadaa90a10e2These 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
71335-0969-02024-01-30C16284748780-11030e365-0f37-111a-e063-dadaa90a10e2These 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
71335-0969-12024-01-30C16284748780-11030e365-0f37-111a-e063-dadaa90a10e2These 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
71335-0969-22024-01-30C16284748780-11030e365-0f37-111a-e063-dadaa90a10e2These 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
71335-0969-32024-01-30C16284748780-11030e365-0f37-111a-e063-dadaa90a10e2These 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
71335-0969-42024-01-30C16284748780-11030e365-0f37-111a-e063-dadaa90a10e2These 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
71335-0969-52024-01-30C16284748780-11030e365-0f37-111a-e063-dadaa90a10e2These 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
71335-0969-62024-01-30C16284748780-11030e365-0f37-111a-e063-dadaa90a10e2These 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
71335-0969-72024-01-30C16284748780-11030e365-0f37-111a-e063-dadaa90a10e2These 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
71335-0969-82024-01-30C16284748780-11030e365-0f37-111a-e063-dadaa90a10e2These 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
71335-0969-92024-01-30C16284748780-11030e365-0f37-111a-e063-dadaa90a10e2These 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
71335-0969-0Sildenafil15 in 1 BOTTLETABLET, FILM COATED157
71335-0969-1Sildenafil10 in 1 BOTTLETABLET, FILM COATED107
71335-0969-2Sildenafil5 in 1 BOTTLETABLET, FILM COATED57
71335-0969-3Sildenafil30 in 1 BOTTLETABLET, FILM COATED307
71335-0969-4Sildenafil2 in 1 BOTTLETABLET, FILM COATED27
71335-0969-5Sildenafil6 in 1 BOTTLETABLET, FILM COATED67
71335-0969-6Sildenafil20 in 1 BOTTLETABLET, FILM COATED207
71335-0969-7Sildenafil4 in 1 BOTTLETABLET, FILM COATED47
71335-0969-8Sildenafil90 in 1 BOTTLETABLET, FILM COATED907
71335-0969-9Sildenafil60 in 1 BOTTLETABLET, FILM COATED607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0969SILDENAFIL TABLET, FILM COATED [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 10 package rows20240518_96ae6733-cef9-46cf-bf4e-5368201943bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN96ae6733-cef9-46cf-bf4e-5368201943bd7
314229sildenafil 100 MG Oral TabletSCD96ae6733-cef9-46cf-bf4e-5368201943bd7
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY96ae6733-cef9-46cf-bf4e-5368201943bd7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0969-07133509690015 TABLET, FILM COATED in 1 BOTTLE (71335-0969-0) 2019-02-070000-00-00NoNoCurrent
71335-0969-17133509690110 TABLET, FILM COATED in 1 BOTTLE (71335-0969-1) 2018-10-180000-00-00NoNoCurrent
71335-0969-2713350969025 TABLET, FILM COATED in 1 BOTTLE (71335-0969-2) 2018-12-210000-00-00NoNoCurrent
71335-0969-37133509690330 TABLET, FILM COATED in 1 BOTTLE (71335-0969-3) 2018-11-050000-00-00NoNoCurrent
71335-0969-4713350969042 TABLET, FILM COATED in 1 BOTTLE (71335-0969-4) 2024-05-170000-00-00NoNoCurrent
71335-0969-5713350969056 TABLET, FILM COATED in 1 BOTTLE (71335-0969-5) 2024-05-170000-00-00NoNoCurrent
71335-0969-67133509690620 TABLET, FILM COATED in 1 BOTTLE (71335-0969-6) 2018-11-280000-00-00NoNoCurrent
71335-0969-7713350969074 TABLET, FILM COATED in 1 BOTTLE (71335-0969-7) 2024-05-170000-00-00NoNoCurrent
71335-0969-87133509690890 TABLET, FILM COATED in 1 BOTTLE (71335-0969-8) 2024-05-170000-00-00NoNoCurrent
71335-0969-97133509690960 TABLET, FILM COATED in 1 BOTTLE (71335-0969-9) 2024-05-170000-00-00NoNoCurrent