SILDENAFIL

Product NDC
61919-755
11-digit product format
619190755
Labeler code
61919
Product ID
61919-755_eac53773-083b-5f20-e053-2a95a90a2b6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA202659
Marketing category
ANDA
Marketing start
2021-01-12
Marketing end
0000-00-00
Substance
SILDENAFIL CITRATE
Active strength
50 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-755-102025-01-30C16284748780-12cef2736-6e10-d83d-e063-dadaa90ab31fSILDENAFIL
61919-755-302025-01-30C16284748780-12cef2736-6e10-d83d-e063-dadaa90ab31fSILDENAFIL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-755-10SILDENAFIL10 in 1 BOTTLETABLET, FILM COATED1011
61919-755-30SILDENAFIL30 in 1 BOTTLETABLET, FILM COATED3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-755-10EA - Each61919-755cfbe3405-b75e-4e73-9b43-6bb3d4f4dba312021-02-05
61919-755-30EA - Each61919-755ac47855a-985d-40f6-9d50-7751392dc07d12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-755SILDENAFIL TABLET, FILM COATED [DIRECT RX]11Legacy NDC, 2 package rows20230524_3b3aae0f-4d1d-0244-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN3b3aae0f-4d1d-0244-e054-00144ff88e8811
312950sildenafil citrate 50 MG Oral TabletPSN3b3aae0f-4d1d-0244-e054-00144ff88e8811
577033sildenafil 20 MG Oral TabletSCD3b3aae0f-4d1d-0244-e054-00144ff88e8811
312950sildenafil 50 MG Oral TabletSCD3b3aae0f-4d1d-0244-e054-00144ff88e8811
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY3b3aae0f-4d1d-0244-e054-00144ff88e8811
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY3b3aae0f-4d1d-0244-e054-00144ff88e8811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-755-106191907551010 TABLET, FILM COATED in 1 BOTTLE (61919-755-10) 2021-01-120000-00-00NoNoCurrent
61919-755-306191907553030 TABLET, FILM COATED in 1 BOTTLE (61919-755-30) 2021-01-120000-00-00NoNoCurrent