FDA.reportPublic FDA data

Sildenafil

Product NDC
71335-1649
11-digit product format
713351649
Labeler code
71335
Product ID
71335-1649_841b6c33-e16d-4bbb-80df-3c35c73287d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203623
Marketing category
ANDA
Marketing start
2014-11-26
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
71335-1649-0Sildenafil50 in 1 BOTTLETABLET, FILM COATED508
71335-1649-1Sildenafil10 in 1 BOTTLETABLET, FILM COATED108
71335-1649-2Sildenafil30 in 1 BOTTLETABLET, FILM COATED308
71335-1649-3Sildenafil7 in 1 BOTTLETABLET, FILM COATED78
71335-1649-4Sildenafil90 in 1 BOTTLETABLET, FILM COATED908
71335-1649-5Sildenafil60 in 1 BOTTLETABLET, FILM COATED608
71335-1649-6Sildenafil20 in 1 BOTTLETABLET, FILM COATED208
71335-1649-7Sildenafil270 in 1 BOTTLETABLET, FILM COATED2708
71335-1649-8Sildenafil15 in 1 BOTTLETABLET, FILM COATED158
71335-1649-9Sildenafil12 in 1 BOTTLETABLET, FILM COATED128

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1649-2EA - Each71335-1649c87f69fc-d3ca-4989-aebf-41a8923e2d5c12023-05-05
71335-1649-4EA - Each71335-1649441ce3cb-087d-4843-819c-60eb66d1464512025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1649SILDENAFIL (SILDENAFIL) TABLET, FILM COATED [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 10 package rows20240823_af5277be-124b-4541-b6b2-bb55246cb8ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNaf5277be-124b-4541-b6b2-bb55246cb8ed8
577033sildenafil 20 MG Oral TabletSCDaf5277be-124b-4541-b6b2-bb55246cb8ed8
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYaf5277be-124b-4541-b6b2-bb55246cb8ed8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1649-07133516490050 TABLET, FILM COATED in 1 BOTTLE (71335-1649-0) 2022-03-010000-00-00NoNoCurrent
71335-1649-17133516490110 TABLET, FILM COATED in 1 BOTTLE (71335-1649-1) 2020-07-090000-00-00NoNoCurrent
71335-1649-27133516490230 TABLET, FILM COATED in 1 BOTTLE (71335-1649-2) 2020-06-240000-00-00NoNoCurrent
71335-1649-3713351649037 TABLET, FILM COATED in 1 BOTTLE (71335-1649-3) 2021-05-100000-00-00NoNoCurrent
71335-1649-47133516490490 TABLET, FILM COATED in 1 BOTTLE (71335-1649-4) 2020-06-230000-00-00NoNoCurrent
71335-1649-57133516490560 TABLET, FILM COATED in 1 BOTTLE (71335-1649-5) 2021-03-310000-00-00NoNoCurrent
71335-1649-67133516490620 TABLET, FILM COATED in 1 BOTTLE (71335-1649-6) 2020-08-130000-00-00NoNoCurrent
71335-1649-771335164907270 TABLET, FILM COATED in 1 BOTTLE (71335-1649-7) 2024-05-300000-00-00NoNoCurrent
71335-1649-87133516490815 TABLET, FILM COATED in 1 BOTTLE (71335-1649-8) 2021-07-120000-00-00NoNoCurrent
71335-1649-97133516490912 TABLET, FILM COATED in 1 BOTTLE (71335-1649-9) 2024-05-300000-00-00NoNoCurrent