FDA.reportPublic FDA data

Sildenafil

Product NDC
71335-2657
11-digit product format
713352657
Labeler code
71335
Product ID
71335-2657_b8d4e426-c062-4c2d-89ca-9bd8d13da405
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091479
Marketing category
ANDA
Marketing start
2012-11-06
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
71335-2657-0Sildenafil50 in 1 BOTTLETABLET, FILM COATED501
71335-2657-1Sildenafil10 in 1 BOTTLETABLET, FILM COATED101
71335-2657-2Sildenafil30 in 1 BOTTLETABLET, FILM COATED301
71335-2657-3Sildenafil7 in 1 BOTTLETABLET, FILM COATED71
71335-2657-4Sildenafil90 in 1 BOTTLETABLET, FILM COATED901
71335-2657-5Sildenafil60 in 1 BOTTLETABLET, FILM COATED601
71335-2657-6Sildenafil20 in 1 BOTTLETABLET, FILM COATED201
71335-2657-7Sildenafil270 in 1 BOTTLETABLET, FILM COATED2701
71335-2657-8Sildenafil15 in 1 BOTTLETABLET, FILM COATED151
71335-2657-9Sildenafil12 in 1 BOTTLETABLET, FILM COATED121

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN486dcfc4-f07a-4a78-86f0-f1c5ae448dc11
577033sildenafil 20 MG Oral TabletSCD486dcfc4-f07a-4a78-86f0-f1c5ae448dc11
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY486dcfc4-f07a-4a78-86f0-f1c5ae448dc11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2657-07133526570050 TABLET, FILM COATED in 1 BOTTLE (71335-2657-0) 2025-06-23NoNoHistorical
71335-2657-17133526570110 TABLET, FILM COATED in 1 BOTTLE (71335-2657-1) 2025-06-23NoNoHistorical
71335-2657-27133526570230 TABLET, FILM COATED in 1 BOTTLE (71335-2657-2) 2025-06-23NoNoHistorical
71335-2657-3713352657037 TABLET, FILM COATED in 1 BOTTLE (71335-2657-3) 2025-06-23NoNoHistorical
71335-2657-47133526570490 TABLET, FILM COATED in 1 BOTTLE (71335-2657-4) 2025-06-23NoNoHistorical
71335-2657-57133526570560 TABLET, FILM COATED in 1 BOTTLE (71335-2657-5) 2025-06-23NoNoHistorical
71335-2657-67133526570620 TABLET, FILM COATED in 1 BOTTLE (71335-2657-6) 2025-06-23NoNoHistorical
71335-2657-771335265707270 TABLET, FILM COATED in 1 BOTTLE (71335-2657-7) 2025-06-23NoNoHistorical
71335-2657-87133526570815 TABLET, FILM COATED in 1 BOTTLE (71335-2657-8) 2025-06-23NoNoHistorical
71335-2657-97133526570912 TABLET, FILM COATED in 1 BOTTLE (71335-2657-9) 2025-06-23NoNoHistorical