FDA.reportPublic FDA data

Sildenafil

Product NDC
71335-1777
11-digit product format
713351777
Labeler code
71335
Product ID
71335-1777_a509bbc3-0f61-4013-8a8f-77bb0cc4a019
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077342
Marketing category
ANDA
Marketing start
2017-12-11
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
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 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
71335-1777-0Sildenafil15 in 1 BOTTLETABLET, FILM COATED15101
71335-1777-1Sildenafil10 in 1 BOTTLETABLET, FILM COATED10101
71335-1777-2Sildenafil5 in 1 BOTTLETABLET, FILM COATED5101
71335-1777-3Sildenafil30 in 1 BOTTLETABLET, FILM COATED30101
71335-1777-4Sildenafil2 in 1 BOTTLETABLET, FILM COATED2101
71335-1777-5Sildenafil6 in 1 BOTTLETABLET, FILM COATED6101
71335-1777-6Sildenafil20 in 1 BOTTLETABLET, FILM COATED20101
71335-1777-7Sildenafil4 in 1 BOTTLETABLET, FILM COATED4101
71335-1777-8Sildenafil90 in 1 BOTTLETABLET, FILM COATED90101
71335-1777-9Sildenafil60 in 1 BOTTLETABLET, FILM COATED60101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1777SILDENAFIL TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 10 package rows20241121_f9ab796c-1912-4137-abec-e8336a850a58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNf9ab796c-1912-4137-abec-e8336a850a58101
314229sildenafil 100 MG Oral TabletSCDf9ab796c-1912-4137-abec-e8336a850a58101
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYf9ab796c-1912-4137-abec-e8336a850a58101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1777-07133517770015 TABLET, FILM COATED in 1 BOTTLE (71335-1777-0) 2024-10-310000-00-00NoNoCurrent
71335-1777-17133517770110 TABLET, FILM COATED in 1 BOTTLE (71335-1777-1) 2021-03-120000-00-00NoNoCurrent
71335-1777-2713351777025 TABLET, FILM COATED in 1 BOTTLE (71335-1777-2) 2021-08-170000-00-00NoNoCurrent
71335-1777-37133517770330 TABLET, FILM COATED in 1 BOTTLE (71335-1777-3) 2021-02-120000-00-00NoNoCurrent
71335-1777-4713351777042 TABLET, FILM COATED in 1 BOTTLE (71335-1777-4) 2024-10-310000-00-00NoNoCurrent
71335-1777-5713351777056 TABLET, FILM COATED in 1 BOTTLE (71335-1777-5) 2024-10-310000-00-00NoNoCurrent
71335-1777-67133517770620 TABLET, FILM COATED in 1 BOTTLE (71335-1777-6) 2021-04-140000-00-00NoNoCurrent
71335-1777-7713351777074 TABLET, FILM COATED in 1 BOTTLE (71335-1777-7) 2024-10-310000-00-00NoNoCurrent
71335-1777-87133517770890 TABLET, FILM COATED in 1 BOTTLE (71335-1777-8) 2021-04-120000-00-00NoNoCurrent
71335-1777-97133517770960 TABLET, FILM COATED in 1 BOTTLE (71335-1777-9) 2024-10-310000-00-00NoNoCurrent