FDA.reportPublic FDA data

SILDENAFIL

Product NDC
76282-644
11-digit product format
762820644
Labeler code
76282
Product ID
76282-644_2feb2e90-dc79-4542-87c5-42653c624704
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL
Dosage form
TABLET
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc.
Application
ANDA207178
Marketing category
ANDA
Marketing start
2022-07-01
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
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 CITRATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui312950, 314228, 314229

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
76282-644-01SILDENAFIL100 in 1 BOTTLETABLET1002
76282-644-30SILDENAFIL30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-644-01EA - Each76282-6449189021e-13be-4386-aa63-5b242ae0504312023-01-09
76282-644-30EA - Each76282-644c38f420e-465f-4ec0-8479-2bd8839cc0e012023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-644SILDENAFIL TABLET [EXELAN PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20220811_1883785c-a1a4-48fe-b722-afacf2875ca8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNcdab7ef5-39cb-45cc-b2bf-5f634f2f54994
312950sildenafil citrate 50 MG Oral TabletPSNcdab7ef5-39cb-45cc-b2bf-5f634f2f54994
314229sildenafil 100 MG Oral TabletSCDcdab7ef5-39cb-45cc-b2bf-5f634f2f54994
312950sildenafil 50 MG Oral TabletSCDcdab7ef5-39cb-45cc-b2bf-5f634f2f54994
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYcdab7ef5-39cb-45cc-b2bf-5f634f2f54994
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYcdab7ef5-39cb-45cc-b2bf-5f634f2f54994
314229sildenafil citrate 100 MG Oral TabletPSN1883785c-a1a4-48fe-b722-afacf2875ca82
314228sildenafil citrate 25 MG Oral TabletPSN1883785c-a1a4-48fe-b722-afacf2875ca82
312950sildenafil citrate 50 MG Oral TabletPSN1883785c-a1a4-48fe-b722-afacf2875ca82
314229sildenafil 100 MG Oral TabletSCD1883785c-a1a4-48fe-b722-afacf2875ca82
314228sildenafil 25 MG Oral TabletSCD1883785c-a1a4-48fe-b722-afacf2875ca82
312950sildenafil 50 MG Oral TabletSCD1883785c-a1a4-48fe-b722-afacf2875ca82
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY1883785c-a1a4-48fe-b722-afacf2875ca82
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY1883785c-a1a4-48fe-b722-afacf2875ca82
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY1883785c-a1a4-48fe-b722-afacf2875ca82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-644-0176282064401100 TABLET in 1 BOTTLE (76282-644-01) 100 tablet2022-07-010000-00-00NoNoCurrent
76282-644-307628206443030 TABLET in 1 BOTTLE (76282-644-30) 30 tablet2022-07-010000-00-00NoNoCurrent