FDA.reportPublic FDA data

SILDENAFIL CITRATE

Product NDC
75834-241
11-digit product format
758340241
Labeler code
75834
Product ID
75834-241_506bb4eb-697e-9d05-e063-6294a90a8f2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL CITRATE
Dosage form
TABLET
Route
ORAL
Labeler
NIVAGEN PHARMACEUTICALS, INC.
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
2027-12-31
Current FDA listing
Yes

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
75834-241-00SILDENAFIL CITRATE1000 in 1 BOTTLETABLET100014
75834-241-01SILDENAFIL CITRATE100 in 1 BOTTLETABLET10014
75834-241-05SILDENAFIL CITRATE500 in 1 BOTTLETABLET50014
75834-241-30SILDENAFIL CITRATE30 in 1 BOTTLETABLET3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-241-00EA - Each75834-2415664ab3d-5ce9-4977-a011-44ae1313a96712022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-241SILDENAFIL CITRATE TABLET [NIVAGEN PHARMACEUTICALS, INC.]11Current NDC, Legacy NDC, 4 package rows20241225_5ac95dd0-57e4-495c-bf8d-b2e5bbe33e20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN5ac95dd0-57e4-495c-bf8d-b2e5bbe33e2014
314228sildenafil citrate 25 MG Oral TabletPSN5ac95dd0-57e4-495c-bf8d-b2e5bbe33e2014
312950sildenafil citrate 50 MG Oral TabletPSN5ac95dd0-57e4-495c-bf8d-b2e5bbe33e2014
314229sildenafil 100 MG Oral TabletSCD5ac95dd0-57e4-495c-bf8d-b2e5bbe33e2014
314228sildenafil 25 MG Oral TabletSCD5ac95dd0-57e4-495c-bf8d-b2e5bbe33e2014
312950sildenafil 50 MG Oral TabletSCD5ac95dd0-57e4-495c-bf8d-b2e5bbe33e2014
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY5ac95dd0-57e4-495c-bf8d-b2e5bbe33e2014
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY5ac95dd0-57e4-495c-bf8d-b2e5bbe33e2014
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY5ac95dd0-57e4-495c-bf8d-b2e5bbe33e2014
314229sildenafil citrate 100 MG Oral TabletPSNf1122baa-8dee-43fc-bd3d-501a55b696b312
314229sildenafil 100 MG Oral TabletSCDf1122baa-8dee-43fc-bd3d-501a55b696b312
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYf1122baa-8dee-43fc-bd3d-501a55b696b312
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
314229sildenafil citrate 100 MG Oral TabletPSN5846bff2-6a93-46a7-a547-04459c5908141
314229sildenafil citrate 100 MG Oral TabletPSN30cb7d6a-ce40-c794-e063-6294a90a68611
314229sildenafil 100 MG Oral TabletSCD5846bff2-6a93-46a7-a547-04459c5908141
314229sildenafil 100 MG Oral TabletSCD30cb7d6a-ce40-c794-e063-6294a90a68611
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY5846bff2-6a93-46a7-a547-04459c5908141
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY30cb7d6a-ce40-c794-e063-6294a90a68611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75834-241-00758340241001000 TABLET in 1 BOTTLE (75834-241-00) 1000 tablet2020-09-040000-00-00NoNoCurrent
75834-241-0175834024101100 TABLET in 1 BOTTLE (75834-241-01) 100 tablet2020-09-040000-00-00NoNoCurrent
75834-241-0575834024105500 TABLET in 1 BOTTLE (75834-241-05) 500 tablet2020-09-040000-00-00NoNoCurrent
75834-241-307583402413030 TABLET in 1 BOTTLE (75834-241-30) 30 tablet2020-09-040000-00-00NoNoCurrent