FDA.reportPublic FDA data

Sildenafil

Product NDC
71205-220
11-digit product format
712050220
Labeler code
71205
Product ID
71205-220_5d593e03-b6f0-41d0-b7b2-e53d2421a903
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203962
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
71205-220-10Sildenafil10 in 1 BOTTLETABLET, FILM COATED102
71205-220-20Sildenafil20 in 1 BOTTLETABLET, FILM COATED202
71205-220-30Sildenafil30 in 1 BOTTLETABLET, FILM COATED302
71205-220-50Sildenafil50 in 1 BOTTLETABLET, FILM COATED502
71205-220-60Sildenafil60 in 1 BOTTLETABLET, FILM COATED602
71205-220-90Sildenafil90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-220-10EA - Each71205-220a5bb383c-0a4d-4756-acda-43287ede55d912019-04-11
71205-220-50EA - Each71205-220331f445c-4f42-4ba5-b298-51a0c63f656d12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-220SILDENAFIL TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 6 package rows20191012_61c3866e-401d-48b3-a0d2-1e24a33ab512.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN61c3866e-401d-48b3-a0d2-1e24a33ab5122
314229sildenafil 100 MG Oral TabletSCD61c3866e-401d-48b3-a0d2-1e24a33ab5122
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY61c3866e-401d-48b3-a0d2-1e24a33ab5122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-220-107120502201010 TABLET, FILM COATED in 1 BOTTLE (71205-220-10) 2019-02-010000-00-00NoNoCurrent
71205-220-207120502202020 TABLET, FILM COATED in 1 BOTTLE (71205-220-20) 2019-02-010000-00-00NoNoCurrent
71205-220-307120502203030 TABLET, FILM COATED in 1 BOTTLE (71205-220-30) 2019-02-010000-00-00NoNoCurrent
71205-220-507120502205050 TABLET, FILM COATED in 1 BOTTLE (71205-220-50) 2019-02-010000-00-00NoNoCurrent
71205-220-607120502206060 TABLET, FILM COATED in 1 BOTTLE (71205-220-60) 2019-02-010000-00-00NoNoCurrent
71205-220-907120502209090 TABLET, FILM COATED in 1 BOTTLE (71205-220-90) 2019-02-010000-00-00NoNoCurrent