FDA.reportPublic FDA data

SILDENAFIL CITRATE

Product NDC
71205-795
11-digit product format
712050795
Labeler code
71205
Product ID
71205-795_6fd94b93-d76c-43d0-a1cc-85fef542960e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL CITRATE
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA209302
Marketing category
ANDA
Marketing start
2020-09-04
Substance
SILDENAFIL CITRATE
Active strength
50 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 CITRATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui312950

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
71205-795-10SILDENAFIL CITRATE10 in 1 BOTTLETABLET103
71205-795-11SILDENAFIL CITRATE1000 in 1 BOTTLETABLET10003
71205-795-20SILDENAFIL CITRATE20 in 1 BOTTLETABLET203
71205-795-30SILDENAFIL CITRATE30 in 1 BOTTLETABLET303
71205-795-60SILDENAFIL CITRATE60 in 1 BOTTLETABLET603
71205-795-90SILDENAFIL CITRATE90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-795-11EA - Each71205-795c4a35927-9d0b-4c29-b361-80f7335704b812025-12-16
71205-795-30EA - Each71205-7951f4ecbc5-0888-4c4f-a905-d84520e640ad12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-795SILDENAFIL CITRATE TABLET [PROFICIENT RX LP]1Current NDC, 6 package rows20230422_8780c159-8b61-402b-afbe-64f5c85d3886.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312950sildenafil citrate 50 MG Oral TabletPSN8780c159-8b61-402b-afbe-64f5c85d38863
312950sildenafil 50 MG Oral TabletSCD8780c159-8b61-402b-afbe-64f5c85d38863
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY8780c159-8b61-402b-afbe-64f5c85d38863

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-795-107120507951010 TABLET in 1 BOTTLE (71205-795-10) 10 tablet2023-04-20NoNoCurrent
71205-795-11712050795111000 TABLET in 1 BOTTLE (71205-795-11) 1000 tablet2025-10-30NoNoCurrent
71205-795-207120507952020 TABLET in 1 BOTTLE (71205-795-20) 20 tablet2023-04-20NoNoCurrent
71205-795-307120507953030 TABLET in 1 BOTTLE (71205-795-30) 30 tablet2023-04-20NoNoCurrent
71205-795-607120507956060 TABLET in 1 BOTTLE (71205-795-60) 60 tablet2023-04-20NoNoCurrent
71205-795-907120507959090 TABLET in 1 BOTTLE (71205-795-90) 90 tablet2023-04-20NoNoCurrent