FDA.reportPublic FDA data

SILDENAFIL CITRATE

Product NDC
71205-657
11-digit product format
712050657
Labeler code
71205
Product ID
71205-657_fd8ab326-7f1b-42b4-a20c-39ed68e79378
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
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 CITRATE
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
71205-657-02SILDENAFIL CITRATE2 in 1 BOTTLETABLET27
71205-657-10SILDENAFIL CITRATE10 in 1 BOTTLETABLET107
71205-657-11SILDENAFIL CITRATE1000 in 1 BOTTLETABLET10007
71205-657-20SILDENAFIL CITRATE20 in 1 BOTTLETABLET207
71205-657-30SILDENAFIL CITRATE30 in 1 BOTTLETABLET307
71205-657-60SILDENAFIL CITRATE60 in 1 BOTTLETABLET607
71205-657-90SILDENAFIL CITRATE90 in 1 BOTTLETABLET907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-657SILDENAFIL CITRATE TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 7 package rows20230711_30ce6e7f-716e-4a68-a4fb-2bb2d34ed052.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN30ce6e7f-716e-4a68-a4fb-2bb2d34ed0527
314229sildenafil 100 MG Oral TabletSCD30ce6e7f-716e-4a68-a4fb-2bb2d34ed0527
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY30ce6e7f-716e-4a68-a4fb-2bb2d34ed0527

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-657-02712050657022 TABLET in 1 BOTTLE (71205-657-02) 2 tablet2023-07-06NoNoCurrent
71205-657-107120506571010 TABLET in 1 BOTTLE (71205-657-10) 10 tablet2022-06-100000-00-00NoNoCurrent
71205-657-11712050657111000 TABLET in 1 BOTTLE (71205-657-11) 1000 tablet2025-10-30NoNoCurrent
71205-657-207120506572020 TABLET in 1 BOTTLE (71205-657-20) 20 tablet2023-01-31NoNoCurrent
71205-657-307120506573030 TABLET in 1 BOTTLE (71205-657-30) 30 tablet2022-05-050000-00-00NoNoCurrent
71205-657-607120506576060 TABLET in 1 BOTTLE (71205-657-60) 60 tablet2022-05-050000-00-00NoNoCurrent
71205-657-907120506579090 TABLET in 1 BOTTLE (71205-657-90) 90 tablet2022-05-050000-00-00NoNoCurrent