FDA.reportPublic FDA data

Sildenafil

Product NDC
63629-7833
11-digit product format
636297833
Labeler code
63629
Product ID
63629-7833_d46344f0-a486-4a8b-b941-bf03c75aa7b3
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
50 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 CITRATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui312950

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
63629-7833-12024-05-14C16284748780-11030e365-0665-111a-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
63629-7833-22024-05-14C16284748780-11030e365-0665-111a-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
63629-7833-32024-05-14C16284748780-11030e365-0665-111a-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
63629-7833-42024-05-14C16284748780-11030e365-0665-111a-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
63629-7833-52024-05-14C16284748780-11030e365-0665-111a-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
63629-7833-62024-05-14C16284748780-11030e365-0665-111a-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
63629-7833-12024-01-30C16284748780-11030e365-0665-111a-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
63629-7833-22024-01-30C16284748780-11030e365-0665-111a-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
63629-7833-32024-01-30C16284748780-11030e365-0665-111a-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
63629-7833-42024-01-30C16284748780-11030e365-0665-111a-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
63629-7833-52024-01-30C16284748780-11030e365-0665-111a-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
63629-7833-62024-01-30C16284748780-11030e365-0665-111a-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
63629-7833-1Sildenafil30 in 1 BOTTLETABLET, FILM COATED309
63629-7833-2Sildenafil10 in 1 BOTTLETABLET, FILM COATED109
63629-7833-3Sildenafil15 in 1 BOTTLETABLET, FILM COATED159
63629-7833-4Sildenafil90 in 1 BOTTLETABLET, FILM COATED909
63629-7833-5Sildenafil60 in 1 BOTTLETABLET, FILM COATED609
63629-7833-6Sildenafil20 in 1 BOTTLETABLET, FILM COATED209
63629-7833-7Sildenafil7 in 1 BOTTLETABLET, FILM COATED79

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7833SILDENAFIL TABLET, FILM COATED [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 7 package rows20240516_dfe4f616-b5de-458c-a97b-ab860e32320c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312950sildenafil citrate 50 MG Oral TabletPSNdfe4f616-b5de-458c-a97b-ab860e32320c9
312950sildenafil 50 MG Oral TabletSCDdfe4f616-b5de-458c-a97b-ab860e32320c9
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYdfe4f616-b5de-458c-a97b-ab860e32320c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7833-16362978330130 TABLET, FILM COATED in 1 BOTTLE (63629-7833-1) 2018-11-130000-00-00NoNoCurrent
63629-7833-26362978330210 TABLET, FILM COATED in 1 BOTTLE (63629-7833-2) 2019-01-280000-00-00NoNoCurrent
63629-7833-36362978330315 TABLET, FILM COATED in 1 BOTTLE (63629-7833-3) 2019-09-130000-00-00NoNoCurrent
63629-7833-46362978330490 TABLET, FILM COATED in 1 BOTTLE (63629-7833-4) 2024-04-030000-00-00NoNoCurrent
63629-7833-56362978330560 TABLET, FILM COATED in 1 BOTTLE (63629-7833-5) 2024-04-030000-00-00NoNoCurrent
63629-7833-66362978330620 TABLET, FILM COATED in 1 BOTTLE (63629-7833-6) 2024-04-030000-00-00NoNoCurrent
63629-7833-7636297833077 TABLET, FILM COATED in 1 BOTTLE (63629-7833-7) 2024-04-03NoNoCurrent