FDA.reportPublic FDA data

Sildenafil

Product NDC
71335-1005
11-digit product format
713351005
Labeler code
71335
Product ID
71335-1005_7dde9c19-f947-49da-bcd3-01430780e173
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203814
Marketing category
ANDA
Marketing start
2014-01-03
Marketing end
2027-10-31
Substance
SILDENAFIL CITRATE
Active strength
20 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sildenafil

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
71335-1005-1Sildenafil10 in 1 BOTTLETABLET, FILM COATED104
71335-1005-2Sildenafil30 in 1 BOTTLETABLET, FILM COATED304
71335-1005-3Sildenafil7 in 1 BOTTLETABLET, FILM COATED74
71335-1005-4Sildenafil90 in 1 BOTTLETABLET, FILM COATED904
71335-1005-5Sildenafil60 in 1 BOTTLETABLET, FILM COATED604
71335-1005-6Sildenafil20 in 1 BOTTLETABLET, FILM COATED204
71335-1005-7Sildenafil270 in 1 BOTTLETABLET, FILM COATED2704
71335-1005-8Sildenafil15 in 1 BOTTLETABLET, FILM COATED154
71335-1005-9Sildenafil12 in 1 BOTTLETABLET, FILM COATED124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1005SILDENAFIL TABLET, FILM COATED [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 9 package rows20231101_7c01fd56-5dd6-4728-9f2a-e0f5db810269.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN7c01fd56-5dd6-4728-9f2a-e0f5db8102694
577033sildenafil 20 MG Oral TabletSCD7c01fd56-5dd6-4728-9f2a-e0f5db8102694
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY7c01fd56-5dd6-4728-9f2a-e0f5db8102694

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1005-17133510050110 TABLET, FILM COATED in 1 BOTTLE (71335-1005-1) 2016-10-142027-10-31NoNoCurrent
71335-1005-27133510050230 TABLET, FILM COATED in 1 BOTTLE (71335-1005-2) 2016-10-142027-10-31NoNoCurrent
71335-1005-3713351005037 TABLET, FILM COATED in 1 BOTTLE (71335-1005-3) 2016-10-142027-10-31NoNoCurrent
71335-1005-47133510050490 TABLET, FILM COATED in 1 BOTTLE (71335-1005-4) 2016-10-142027-10-31NoNoCurrent
71335-1005-57133510050560 TABLET, FILM COATED in 1 BOTTLE (71335-1005-5) 2016-10-142027-10-31NoNoCurrent
71335-1005-67133510050620 TABLET, FILM COATED in 1 BOTTLE (71335-1005-6) 2016-10-142027-10-31NoNoCurrent
71335-1005-771335100507270 TABLET, FILM COATED in 1 BOTTLE (71335-1005-7) 2016-10-142027-10-31NoNoCurrent
71335-1005-87133510050815 TABLET, FILM COATED in 1 BOTTLE (71335-1005-8) 2016-10-142027-10-31NoNoCurrent
71335-1005-97133510050912 TABLET, FILM COATED in 1 BOTTLE (71335-1005-9) 2016-10-142027-10-31NoNoCurrent