FDA.reportPublic FDA data

SILDENAFIL CITRATE

Product NDC
71335-3111
11-digit product format
713353111
Labeler code
71335
Product ID
71335-3111_8dfbbbc6-2ad4-4aaa-a7ec-17dc31e3efd3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091448
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SILDENAFIL CITRATE
Listing expiration
2027-12-31

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
71335-3111-1SILDENAFIL CITRATE30 in 1 BOTTLETABLET, FILM COATED301
71335-3111-2SILDENAFIL CITRATE10 in 1 BOTTLETABLET, FILM COATED101
71335-3111-3SILDENAFIL CITRATE15 in 1 BOTTLETABLET, FILM COATED151
71335-3111-4SILDENAFIL CITRATE90 in 1 BOTTLETABLET, FILM COATED901
71335-3111-5SILDENAFIL CITRATE60 in 1 BOTTLETABLET, FILM COATED601
71335-3111-6SILDENAFIL CITRATE20 in 1 BOTTLETABLET, FILM COATED201
71335-3111-7SILDENAFIL CITRATE7 in 1 BOTTLETABLET, FILM COATED71
71335-3111-8SILDENAFIL CITRATE40 in 1 BOTTLETABLET, FILM COATED401

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312950sildenafil citrate 50 MG Oral TabletPSNa05ab4e7-6f70-41c3-a3b7-9a2fd7a1d2d61
312950sildenafil 50 MG Oral TabletSCDa05ab4e7-6f70-41c3-a3b7-9a2fd7a1d2d61
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYa05ab4e7-6f70-41c3-a3b7-9a2fd7a1d2d61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-3111-17133531110130 TABLET, FILM COATED in 1 BOTTLE (71335-3111-1) 2026-03-30NoNoHistorical
71335-3111-27133531110210 TABLET, FILM COATED in 1 BOTTLE (71335-3111-2) 2026-03-30NoNoHistorical
71335-3111-37133531110315 TABLET, FILM COATED in 1 BOTTLE (71335-3111-3) 2026-03-30NoNoHistorical
71335-3111-47133531110490 TABLET, FILM COATED in 1 BOTTLE (71335-3111-4) 2026-03-30NoNoHistorical
71335-3111-57133531110560 TABLET, FILM COATED in 1 BOTTLE (71335-3111-5) 2026-03-30NoNoHistorical
71335-3111-67133531110620 TABLET, FILM COATED in 1 BOTTLE (71335-3111-6) 2026-03-30NoNoHistorical
71335-3111-7713353111077 TABLET, FILM COATED in 1 BOTTLE (71335-3111-7) 2026-03-30NoNoHistorical
71335-3111-87133531110840 TABLET, FILM COATED in 1 BOTTLE (71335-3111-8) 2026-03-30NoNoHistorical