FDA.reportPublic FDA data

Sildenafil

Product NDC
63629-5029
11-digit product format
636295029
Labeler code
63629
Product ID
63629-5029_9b2a355b-6ad7-44e7-97a0-9cc736fa479e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202025
Marketing category
ANDA
Marketing start
2012-11-08
Substance
SILDENAFIL CITRATE
Active strength
20 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 CITRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui577033

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
63629-5029-02024-05-16C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-12024-05-16C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-22024-05-16C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-32024-05-16C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-42024-05-16C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-52024-05-16C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-62024-05-16C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-72024-05-16C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-82024-05-16C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-92024-05-16C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-02024-01-30C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-12024-01-30C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-22024-01-30C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-32024-01-30C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-42024-01-30C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-52024-01-30C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-62024-01-30C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-72024-01-30C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-82024-01-30C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-92024-01-30C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-12022-02-25C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-22022-02-25C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-32022-02-25C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-12019-11-27C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-22019-11-27C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-32019-11-27C16284748780-19855d018-e8ee-cd31-e053-dbdaa90ab51aThese 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
63629-5029-0Sildenafil50 in 1 BOTTLETABLET501003
63629-5029-1Sildenafil10 in 1 BOTTLETABLET101003
63629-5029-2Sildenafil30 in 1 BOTTLETABLET301003
63629-5029-3Sildenafil7 in 1 BOTTLETABLET71003
63629-5029-4Sildenafil90 in 1 BOTTLETABLET901003
63629-5029-5Sildenafil60 in 1 BOTTLETABLET601003
63629-5029-6Sildenafil20 in 1 BOTTLETABLET201003
63629-5029-7Sildenafil270 in 1 BOTTLETABLET2701003
63629-5029-8Sildenafil15 in 1 BOTTLETABLET151003
63629-5029-9Sildenafil12 in 1 BOTTLETABLET121003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-5029-1EA - Each63629-50297410193e-1c37-4d46-8813-35f2a7d47e9912017-04-05
63629-5029-2EA - Each63629-5029db8e10dd-78c8-4a54-a60a-da1b8c10b4ec12017-04-05
63629-5029-3EA - Each63629-502984b4bef2-0fcc-45e1-8cd9-1ddd7145c05b12017-04-05
63629-5029-4EA - Each63629-50294b3eab8b-3b9c-4b1d-b99e-d402456d090f12022-03-09
63629-5029-5EA - Each63629-50291bf359fb-9f8a-4cee-bf71-b4d296888fc412022-03-09
63629-5029-6EA - Each63629-5029a80f4243-05fc-4075-a680-31463762d13e12022-03-09
63629-5029-7EA - Each63629-502914361616-be60-4c15-8c62-aaf3c25e11ff12022-03-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SILDENAFILACTIVE INGREDIENT3M7OB98Y7HSILDENAFIL TABLET [BRYANT RANCH PREPACK]1000
SILDENAFILACTIVE MOIETY3M7OB98Y7HSILDENAFIL TABLET [BRYANT RANCH PREPACK]1000
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSILDENAFIL TABLET [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USILDENAFIL TABLET [BRYANT RANCH PREPACK]1000
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SILDENAFIL TABLET [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSILDENAFIL TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SILDENAFIL TABLET [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASILDENAFIL TABLET [BRYANT RANCH PREPACK]1000
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SILDENAFIL TABLET [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1USILDENAFIL TABLET [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSILDENAFIL TABLET [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5029SILDENAFIL TABLET [BRYANT RANCH PREPACK]1003Current NDC, Legacy NDC, 10 package rows20240518_a636d3c7-af25-4148-8b4e-6f44deba700b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNa636d3c7-af25-4148-8b4e-6f44deba700b1003
577033sildenafil 20 MG Oral TabletSCDa636d3c7-af25-4148-8b4e-6f44deba700b1003
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYa636d3c7-af25-4148-8b4e-6f44deba700b1003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-5029-06362950290050 TABLET in 1 BOTTLE (63629-5029-0) 50 tablet2024-04-020000-00-00NoNoCurrent
63629-5029-16362950290110 TABLET in 1 BOTTLE (63629-5029-1) 10 tablet2013-08-210000-00-00NoNoCurrent
63629-5029-26362950290230 TABLET in 1 BOTTLE (63629-5029-2) 30 tablet2013-06-060000-00-00NoNoCurrent
63629-5029-3636295029037 TABLET in 1 BOTTLE (63629-5029-3) 7 tablet2013-08-020000-00-00NoNoCurrent
63629-5029-46362950290490 TABLET in 1 BOTTLE (63629-5029-4) 90 tablet2014-05-080000-00-00NoNoCurrent
63629-5029-56362950290560 TABLET in 1 BOTTLE (63629-5029-5) 60 tablet2018-03-280000-00-00NoNoCurrent
63629-5029-66362950290620 TABLET in 1 BOTTLE (63629-5029-6) 20 tablet2016-03-240000-00-00NoNoCurrent
63629-5029-763629502907270 TABLET in 1 BOTTLE (63629-5029-7) 270 tablet2024-04-020000-00-00NoNoCurrent
63629-5029-86362950290815 TABLET in 1 BOTTLE (63629-5029-8) 15 tablet2024-04-020000-00-00NoNoCurrent
63629-5029-96362950290912 TABLET in 1 BOTTLE (63629-5029-9) 12 tablet2017-10-250000-00-00NoNoCurrent