FDA.reportPublic FDA data

SILDENAFIL CITRATE

Product NDC
71335-3049
11-digit product format
713353049
Labeler code
71335
Product ID
71335-3049_adbe8233-4bc1-41ee-8ef7-870ae3e369c4
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
100 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 CITRATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui314229

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
71335-3049-0SILDENAFIL CITRATE15 in 1 BOTTLETABLET, FILM COATED15100
71335-3049-1SILDENAFIL CITRATE10 in 1 BOTTLETABLET, FILM COATED10100
71335-3049-2SILDENAFIL CITRATE5 in 1 BOTTLETABLET, FILM COATED5100
71335-3049-3SILDENAFIL CITRATE30 in 1 BOTTLETABLET, FILM COATED30100
71335-3049-4SILDENAFIL CITRATE2 in 1 BOTTLETABLET, FILM COATED2100
71335-3049-5SILDENAFIL CITRATE6 in 1 BOTTLETABLET, FILM COATED6100
71335-3049-6SILDENAFIL CITRATE20 in 1 BOTTLETABLET, FILM COATED20100
71335-3049-7SILDENAFIL CITRATE4 in 1 BOTTLETABLET, FILM COATED4100
71335-3049-8SILDENAFIL CITRATE90 in 1 BOTTLETABLET, FILM COATED90100
71335-3049-9SILDENAFIL CITRATE60 in 1 BOTTLETABLET, FILM COATED60100

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNedb0919d-cbf1-4968-b0eb-342aa811c2ce100
314229sildenafil 100 MG Oral TabletSCDedb0919d-cbf1-4968-b0eb-342aa811c2ce100
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYedb0919d-cbf1-4968-b0eb-342aa811c2ce100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-3049-07133530490015 TABLET, FILM COATED in 1 BOTTLE (71335-3049-0) 2026-03-09NoNoHistorical
71335-3049-17133530490110 TABLET, FILM COATED in 1 BOTTLE (71335-3049-1) 2026-03-09NoNoHistorical
71335-3049-2713353049025 TABLET, FILM COATED in 1 BOTTLE (71335-3049-2) 2026-03-09NoNoHistorical
71335-3049-37133530490330 TABLET, FILM COATED in 1 BOTTLE (71335-3049-3) 2026-03-09NoNoHistorical
71335-3049-4713353049042 TABLET, FILM COATED in 1 BOTTLE (71335-3049-4) 2026-03-09NoNoHistorical
71335-3049-5713353049056 TABLET, FILM COATED in 1 BOTTLE (71335-3049-5) 2026-03-09NoNoHistorical
71335-3049-67133530490620 TABLET, FILM COATED in 1 BOTTLE (71335-3049-6) 2026-03-09NoNoHistorical
71335-3049-7713353049074 TABLET, FILM COATED in 1 BOTTLE (71335-3049-7) 2026-03-09NoNoHistorical
71335-3049-87133530490890 TABLET, FILM COATED in 1 BOTTLE (71335-3049-8) 2026-03-09NoNoHistorical
71335-3049-97133530490960 TABLET, FILM COATED in 1 BOTTLE (71335-3049-9) 2026-03-09NoNoHistorical