FDA.reportPublic FDA data

Sildenafil Citrate

Product NDC
71205-305
11-digit product format
712050305
Labeler code
71205
Product ID
71205-305_4f09b702-450f-4270-8e1a-2402677095cd
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
2019-01-01
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
71205-305-10Sildenafil Citrate10 in 1 BOTTLETABLET, FILM COATED102
71205-305-20Sildenafil Citrate20 in 1 BOTTLETABLET, FILM COATED202
71205-305-30Sildenafil Citrate30 in 1 BOTTLETABLET, FILM COATED302
71205-305-60Sildenafil Citrate60 in 1 BOTTLETABLET, FILM COATED602
71205-305-90Sildenafil Citrate90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-305-30EA - Each71205-30538f09053-300d-4ccc-8712-4ae43b608ec812019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-305SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 5 package rows20191005_9ebc1a11-3f4b-4eb3-89f5-f430a330887d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN9ebc1a11-3f4b-4eb3-89f5-f430a330887d2
577033sildenafil 20 MG Oral TabletSCD9ebc1a11-3f4b-4eb3-89f5-f430a330887d2
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY9ebc1a11-3f4b-4eb3-89f5-f430a330887d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-305-107120503051010 TABLET, FILM COATED in 1 BOTTLE (71205-305-10) 2019-08-010000-00-00NoNoCurrent
71205-305-207120503052020 TABLET, FILM COATED in 1 BOTTLE (71205-305-20) 2019-08-010000-00-00NoNoCurrent
71205-305-307120503053030 TABLET, FILM COATED in 1 BOTTLE (71205-305-30) 2019-08-010000-00-00NoNoCurrent
71205-305-607120503056060 TABLET, FILM COATED in 1 BOTTLE (71205-305-60) 2019-08-010000-00-00NoNoCurrent
71205-305-907120503059090 TABLET, FILM COATED in 1 BOTTLE (71205-305-90) 2019-08-010000-00-00NoNoCurrent