FDA.reportPublic FDA data

Sildenafil

Product NDC
71205-509
11-digit product format
712050509
Labeler code
71205
Product ID
71205-509_72c1516f-8a0c-495c-b11f-93bdc574ad21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078380
Marketing category
ANDA
Marketing start
2013-05-31
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
ac996ae9-22a2-41c2-bb86-913c4aef95adProduct name120230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fcProduct name920220613
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-509-30Sildenafil30 in 1 BOTTLETABLET, FILM COATED301
71205-509-60Sildenafil60 in 1 BOTTLETABLET, FILM COATED601
71205-509-90Sildenafil90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-509-90EA - Each71205-509278217e0-4ffb-4342-9cac-6998adb3017312021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-509SILDENAFIL TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, Legacy NDC, 3 package rows20201201_72c1516f-8a0c-495c-b11f-93bdc574ad21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN72c1516f-8a0c-495c-b11f-93bdc574ad211
577033sildenafil 20 MG Oral TabletSCD72c1516f-8a0c-495c-b11f-93bdc574ad211
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY72c1516f-8a0c-495c-b11f-93bdc574ad211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-509-307120505093030 TABLET, FILM COATED in 1 BOTTLE (71205-509-30) 2020-11-240000-00-00NoNoCurrent
71205-509-607120505096060 TABLET, FILM COATED in 1 BOTTLE (71205-509-60) 2020-11-240000-00-00NoNoCurrent
71205-509-907120505099090 TABLET, FILM COATED in 1 BOTTLE (71205-509-90) 2020-11-240000-00-00NoNoCurrent