FDA.reportPublic FDA data

SILDENAFIL

Product NDC
71205-473
11-digit product format
712050473
Labeler code
71205
Product ID
71205-473_1d2a3b34-3e71-4a4b-81ed-4ff35976abc0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA207178
Marketing category
ANDA
Marketing start
2020-07-10
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
71205-473-10SILDENAFIL10 in 1 BOTTLETABLET102
71205-473-20SILDENAFIL20 in 1 BOTTLETABLET202
71205-473-30SILDENAFIL30 in 1 BOTTLETABLET302
71205-473-60SILDENAFIL60 in 1 BOTTLETABLET602
71205-473-90SILDENAFIL90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-473-20EA - Each71205-47357292f30-3c8d-4a59-8182-094d4b8e665612021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-473SILDENAFIL TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 5 package rows20210330_7086e222-0f2b-4c02-84c0-4f8635c90993.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN7086e222-0f2b-4c02-84c0-4f8635c909932
314229sildenafil 100 MG Oral TabletSCD7086e222-0f2b-4c02-84c0-4f8635c909932
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY7086e222-0f2b-4c02-84c0-4f8635c909932

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-473-107120504731010 TABLET in 1 BOTTLE (71205-473-10) 10 tablet2020-08-240000-00-00NoNoCurrent
71205-473-207120504732020 TABLET in 1 BOTTLE (71205-473-20) 20 tablet2021-03-230000-00-00NoNoCurrent
71205-473-307120504733030 TABLET in 1 BOTTLE (71205-473-30) 30 tablet2020-08-240000-00-00NoNoCurrent
71205-473-607120504736060 TABLET in 1 BOTTLE (71205-473-60) 60 tablet2020-08-240000-00-00NoNoCurrent
71205-473-907120504739090 TABLET in 1 BOTTLE (71205-473-90) 90 tablet2020-08-240000-00-00NoNoCurrent