FDA.reportPublic FDA data

Sildenafil Citrate

Product NDC
71205-623
11-digit product format
712050623
Labeler code
71205
Product ID
71205-623_ad418ee5-a646-4d79-b10b-c7f3051f2977
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204883
Marketing category
ANDA
Marketing start
2016-08-01
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 Citrate
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
71205-623-10Sildenafil Citrate10 in 1 BOTTLETABLET, FILM COATED104
71205-623-30Sildenafil Citrate30 in 1 BOTTLETABLET, FILM COATED304
71205-623-60Sildenafil Citrate60 in 1 BOTTLETABLET, FILM COATED604
71205-623-90Sildenafil Citrate90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-623-10EA - Each71205-623231873a0-ed1b-4e50-b935-2e3042e5291112024-02-14
71205-623-30EA - Each71205-62324915c12-b866-4d02-9a1e-d98ec4a2b5c012022-03-09
71205-623-90EA - Each71205-623d97ccf7d-4821-4238-b8bf-16159d45932012022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-623SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 4 package rows20240123_88825206-1b91-4d95-876c-71100912d378.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN88825206-1b91-4d95-876c-71100912d3784
577033sildenafil 20 MG Oral TabletSCD88825206-1b91-4d95-876c-71100912d3784
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY88825206-1b91-4d95-876c-71100912d3784

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-623-107120506231010 TABLET, FILM COATED in 1 BOTTLE (71205-623-10) 2021-12-29NoNoCurrent
71205-623-307120506233030 TABLET, FILM COATED in 1 BOTTLE (71205-623-30) 2021-11-230000-00-00NoNoCurrent
71205-623-607120506236060 TABLET, FILM COATED in 1 BOTTLE (71205-623-60) 2021-11-230000-00-00NoNoCurrent
71205-623-907120506239090 TABLET, FILM COATED in 1 BOTTLE (71205-623-90) 2021-11-230000-00-00NoNoCurrent