FDA.reportPublic FDA data

Sildenafil

Product NDC
63187-813
11-digit product format
631870813
Labeler code
63187
Product ID
63187-813_46ab16a5-1f10-4772-97c6-272c4d28164e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203814
Marketing category
ANDA
Marketing start
2014-01-03
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
63187-813-10Sildenafil10 in 1 BOTTLETABLET, FILM COATED103
63187-813-30Sildenafil30 in 1 BOTTLETABLET, FILM COATED303
63187-813-50Sildenafil50 in 1 BOTTLETABLET, FILM COATED503
63187-813-60Sildenafil60 in 1 BOTTLETABLET, FILM COATED603
63187-813-90Sildenafil90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-813-30EA - Each63187-8136501e437-35e8-40eb-8759-79e63626e14012017-03-06
63187-813-50EA - Each63187-813fadbb686-2e40-4447-a606-92bc13f0e71612017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-813SILDENAFIL TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 5 package rows20191113_2538995d-2df6-4c87-978a-5513c670b60f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN2538995d-2df6-4c87-978a-5513c670b60f3
577033sildenafil 20 MG Oral TabletSCD2538995d-2df6-4c87-978a-5513c670b60f3
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY2538995d-2df6-4c87-978a-5513c670b60f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-813-106318708131010 TABLET, FILM COATED in 1 BOTTLE (63187-813-10) 2017-02-010000-00-00NoNoCurrent
63187-813-306318708133030 TABLET, FILM COATED in 1 BOTTLE (63187-813-30) 2017-02-010000-00-00NoNoCurrent
63187-813-506318708135050 TABLET, FILM COATED in 1 BOTTLE (63187-813-50) 2017-02-010000-00-00NoNoCurrent
63187-813-606318708136060 TABLET, FILM COATED in 1 BOTTLE (63187-813-60) 2017-02-010000-00-00NoNoCurrent
63187-813-906318708139090 TABLET, FILM COATED in 1 BOTTLE (63187-813-90) 2017-02-010000-00-00NoNoCurrent