FDA.reportPublic FDA data

Sildenafil

Product NDC
71335-1028
11-digit product format
713351028
Labeler code
71335
Product ID
71335-1028_e6ae2071-5888-4010-9a90-b4297b78bb9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202659
Marketing category
ANDA
Marketing start
2018-06-11
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1028-1Sildenafil30 in 1 BOTTLETABLET, FILM COATED308
71335-1028-2Sildenafil10 in 1 BOTTLETABLET, FILM COATED108
71335-1028-3Sildenafil15 in 1 BOTTLETABLET, FILM COATED158
71335-1028-4Sildenafil90 in 1 BOTTLETABLET, FILM COATED908
71335-1028-5Sildenafil60 in 1 BOTTLETABLET, FILM COATED608
71335-1028-6Sildenafil20 in 1 BOTTLETABLET, FILM COATED208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1028-2EA - Each71335-1028404e2a64-9c1f-408f-ad80-b2b89b34692512023-12-05
71335-1028-3EA - Each71335-102878b4cb3a-8f47-470d-a09c-df179c34cf9b12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1028SILDENAFIL TABLET, FILM COATED [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 6 package rows20240809_e22902bd-e5a8-4df6-ae77-8a0a1484cc50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312950sildenafil citrate 50 MG Oral TabletPSNe22902bd-e5a8-4df6-ae77-8a0a1484cc508
312950sildenafil 50 MG Oral TabletSCDe22902bd-e5a8-4df6-ae77-8a0a1484cc508
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYe22902bd-e5a8-4df6-ae77-8a0a1484cc508

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1028-17133510280130 TABLET, FILM COATED in 1 BOTTLE (71335-1028-1) 2019-07-120000-00-00NoNoCurrent
71335-1028-27133510280210 TABLET, FILM COATED in 1 BOTTLE (71335-1028-2) 2018-12-130000-00-00NoNoCurrent
71335-1028-37133510280315 TABLET, FILM COATED in 1 BOTTLE (71335-1028-3) 2019-07-110000-00-00NoNoCurrent
71335-1028-47133510280490 TABLET, FILM COATED in 1 BOTTLE (71335-1028-4) 2021-02-090000-00-00NoNoCurrent
71335-1028-57133510280560 TABLET, FILM COATED in 1 BOTTLE (71335-1028-5) 2019-11-210000-00-00NoNoCurrent
71335-1028-67133510280620 TABLET, FILM COATED in 1 BOTTLE (71335-1028-6) 2021-09-070000-00-00NoNoCurrent