FDA.reportPublic FDA data

Sildenafil

Product NDC
71335-1963
11-digit product format
713351963
Labeler code
71335
Product ID
71335-1963_8cf40711-534a-4663-9a3b-d92dcc1fe0e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210394
Marketing category
ANDA
Marketing start
2018-05-04
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1963-0Sildenafil50 in 1 BOTTLETABLET50104
71335-1963-1Sildenafil10 in 1 BOTTLETABLET10104
71335-1963-2Sildenafil30 in 1 BOTTLETABLET30104
71335-1963-3Sildenafil7 in 1 BOTTLETABLET7104
71335-1963-4Sildenafil90 in 1 BOTTLETABLET90104
71335-1963-5Sildenafil60 in 1 BOTTLETABLET60104
71335-1963-6Sildenafil20 in 1 BOTTLETABLET20104
71335-1963-7Sildenafil270 in 1 BOTTLETABLET270104
71335-1963-8Sildenafil15 in 1 BOTTLETABLET15104
71335-1963-9Sildenafil12 in 1 BOTTLETABLET12104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1963SILDENAFIL TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 10 package rows20240830_fe848310-57d8-4492-829c-3e2535754a55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNfe848310-57d8-4492-829c-3e2535754a55104
577033sildenafil 20 MG Oral TabletSCDfe848310-57d8-4492-829c-3e2535754a55104
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYfe848310-57d8-4492-829c-3e2535754a55104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1963-07133519630050 TABLET in 1 BOTTLE (71335-1963-0) 50 tablet2022-02-140000-00-00NoNoCurrent
71335-1963-17133519630110 TABLET in 1 BOTTLE (71335-1963-1) 10 tablet2022-02-140000-00-00NoNoCurrent
71335-1963-27133519630230 TABLET in 1 BOTTLE (71335-1963-2) 30 tablet2021-10-060000-00-00NoNoCurrent
71335-1963-3713351963037 TABLET in 1 BOTTLE (71335-1963-3) 7 tablet2022-02-140000-00-00NoNoCurrent
71335-1963-47133519630490 TABLET in 1 BOTTLE (71335-1963-4) 90 tablet2021-11-220000-00-00NoNoCurrent
71335-1963-57133519630560 TABLET in 1 BOTTLE (71335-1963-5) 60 tablet2022-02-140000-00-00NoNoCurrent
71335-1963-67133519630620 TABLET in 1 BOTTLE (71335-1963-6) 20 tablet2021-11-290000-00-00NoNoCurrent
71335-1963-771335196307270 TABLET in 1 BOTTLE (71335-1963-7) 270 tablet2022-02-140000-00-00NoNoCurrent
71335-1963-87133519630815 TABLET in 1 BOTTLE (71335-1963-8) 15 tablet2022-02-140000-00-00NoNoCurrent
71335-1963-97133519630912 TABLET in 1 BOTTLE (71335-1963-9) 12 tablet2022-02-140000-00-00NoNoCurrent