FDA.reportPublic FDA data

Sildenafil

Product NDC
63187-619
11-digit product format
631870619
Labeler code
63187
Product ID
63187-619_71f30593-dbe4-4344-a576-6b6432ce3c64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203623
Marketing category
ANDA
Marketing start
2014-11-26
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
63187-619-10Sildenafil10 in 1 BOTTLETABLET, FILM COATED106
63187-619-30Sildenafil30 in 1 BOTTLETABLET, FILM COATED306
63187-619-60Sildenafil90 in 1 BOTTLETABLET, FILM COATED906
63187-619-90Sildenafil60 in 1 BOTTLETABLET, FILM COATED606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-619-10EA - Each63187-61951070ed5-c08c-4d9c-bdba-ac5f2eccf1ba12023-08-08
63187-619-30EA - Each63187-619d9c94219-5a18-4b49-a7c3-613108951cea12017-07-07
63187-619-90EA - Each63187-6199c805ab0-4060-41f9-90a5-7b788e5038f312023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-619SILDENAFIL TABLET, FILM COATED [PROFICIENT RX LP]6Current NDC, Legacy NDC, 4 package rows20220602_55a53f64-c04a-4697-9db3-d0827fdfcc2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN55a53f64-c04a-4697-9db3-d0827fdfcc2b6
577033sildenafil 20 MG Oral TabletSCD55a53f64-c04a-4697-9db3-d0827fdfcc2b6
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY55a53f64-c04a-4697-9db3-d0827fdfcc2b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-619-106318706191010 TABLET, FILM COATED in 1 BOTTLE (63187-619-10) 2018-12-010000-00-00NoNoCurrent
63187-619-306318706193030 TABLET, FILM COATED in 1 BOTTLE (63187-619-30) 2018-12-010000-00-00NoNoCurrent
63187-619-606318706196090 TABLET, FILM COATED in 1 BOTTLE (63187-619-60) 2018-12-010000-00-00NoNoCurrent
63187-619-906318706199060 TABLET, FILM COATED in 1 BOTTLE (63187-619-90) 2018-12-010000-00-00NoNoCurrent