FDA.reportPublic FDA data

Sildenafil

Product NDC
71205-498
11-digit product format
712050498
Labeler code
71205
Product ID
71205-498_fcc16d82-43ed-4928-9f4a-42c61af347e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202659
Marketing category
ANDA
Marketing start
2018-06-11
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
71205-498-02Sildenafil2 in 1 BOTTLETABLET, FILM COATED23
71205-498-10Sildenafil10 in 1 BOTTLETABLET, FILM COATED103
71205-498-20Sildenafil20 in 1 BOTTLETABLET, FILM COATED203
71205-498-30Sildenafil30 in 1 BOTTLETABLET, FILM COATED303
71205-498-60Sildenafil60 in 1 BOTTLETABLET, FILM COATED603
71205-498-90Sildenafil90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-498SILDENAFIL TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 6 package rows20220528_0aced3eb-cb0b-4135-905c-b274505aa740.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN0aced3eb-cb0b-4135-905c-b274505aa7403
314229sildenafil 100 MG Oral TabletSCD0aced3eb-cb0b-4135-905c-b274505aa7403
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY0aced3eb-cb0b-4135-905c-b274505aa7403

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-498-02712050498022 TABLET, FILM COATED in 1 BOTTLE (71205-498-02) 2021-10-280000-00-00NoNoCurrent
71205-498-107120504981010 TABLET, FILM COATED in 1 BOTTLE (71205-498-10) 2020-10-280000-00-00NoNoCurrent
71205-498-207120504982020 TABLET, FILM COATED in 1 BOTTLE (71205-498-20) 2020-10-280000-00-00NoNoCurrent
71205-498-307120504983030 TABLET, FILM COATED in 1 BOTTLE (71205-498-30) 2020-10-280000-00-00NoNoCurrent
71205-498-607120504986060 TABLET, FILM COATED in 1 BOTTLE (71205-498-60) 2020-10-280000-00-00NoNoCurrent
71205-498-907120504989090 TABLET, FILM COATED in 1 BOTTLE (71205-498-90) 2020-10-280000-00-00NoNoCurrent