FDA.reportPublic FDA data

Sildenafil

Product NDC
63187-789
11-digit product format
631870789
Labeler code
63187
Product ID
63187-789_ab4d1c94-4535-4233-8521-6ec8059b7a05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202025
Marketing category
ANDA
Marketing start
2012-11-08
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
63187-789-10Sildenafil10 in 1 BOTTLETABLET106
63187-789-20Sildenafil20 in 1 BOTTLETABLET206
63187-789-30Sildenafil30 in 1 BOTTLETABLET306
63187-789-50Sildenafil50 in 1 BOTTLETABLET506
63187-789-60Sildenafil60 in 1 BOTTLETABLET606
63187-789-90Sildenafil90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-789-10EA - Each63187-7890c6f4fd4-3a86-4689-be8f-6e2d410b89c212018-03-08
63187-789-20EA - Each63187-7899e0b5858-9e3d-4c42-b83d-a1e65948d70112019-02-13
63187-789-30EA - Each63187-789e5fc691e-9cbe-45c7-9e54-4cd2d2b5fcd412018-02-20
63187-789-50EA - Each63187-789e096977b-29d0-4bef-9edd-3db787fdcecf12017-03-06
63187-789-90EA - Each63187-7893c32a2f6-aaa1-42e6-8b4b-40c05c566f4d12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-789SILDENAFIL TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 6 package rows20200218_38a5592a-c14a-40af-a19a-588cb11090ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN38a5592a-c14a-40af-a19a-588cb11090ed6
577033sildenafil 20 MG Oral TabletSCD38a5592a-c14a-40af-a19a-588cb11090ed6
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY38a5592a-c14a-40af-a19a-588cb11090ed6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-789-106318707891010 TABLET in 1 BOTTLE (63187-789-10) 10 tablet2018-01-010000-00-00NoNoCurrent
63187-789-206318707892020 TABLET in 1 BOTTLE (63187-789-20) 20 tablet2018-11-010000-00-00NoNoCurrent
63187-789-306318707893030 TABLET in 1 BOTTLE (63187-789-30) 30 tablet2016-12-010000-00-00NoNoCurrent
63187-789-506318707895050 TABLET in 1 BOTTLE (63187-789-50) 50 tablet2016-12-010000-00-00NoNoCurrent
63187-789-606318707896060 TABLET in 1 BOTTLE (63187-789-60) 60 tablet2016-12-010000-00-00NoNoCurrent
63187-789-906318707899090 TABLET in 1 BOTTLE (63187-789-90) 90 tablet2016-12-010000-00-00NoNoCurrent