FDA.reportPublic FDA data

Sildenafil Citrate

Product NDC
42543-005
11-digit product format
425430005
Labeler code
42543
Product ID
42543-005_8105c242-9717-453e-b4ef-b6e18633cda5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Vensun Pharmaceuticals, Inc.
Application
ANDA204883
Marketing category
ANDA
Marketing start
2016-08-01
Marketing end
0000-00-00
Substance
SILDENAFIL CITRATE
Active strength
20 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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
42543-005-102020-01-31C16284748780-19d75b9cf-fae2-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
42543-005-902020-01-31C16284748780-19d75b9cf-fae2-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42543-005-10Sildenafil Citrate1000 in 1 BOTTLETABLET, FILM COATED10006
42543-005-90Sildenafil Citrate90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42543-005-10EA - Each42543-0056569235d-3496-4396-96ca-b82f2b9e217412017-08-11
42543-005-90EA - Each42543-00532b7cb01-8f0b-46d4-bfb4-06ebfcbb874812017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42543-005SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [VENSUN PHARMACEUTICALS, INC. ]6Legacy NDC, 2 package rows20180612_a3752548-1472-48b6-9998-119f8a9ecb8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNa3752548-1472-48b6-9998-119f8a9ecb8d6
577033sildenafil 20 MG Oral TabletSCDa3752548-1472-48b6-9998-119f8a9ecb8d6
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYa3752548-1472-48b6-9998-119f8a9ecb8d6
577033sildenafil citrate 20 MG Oral TabletPSN5d19bb9a-c352-4e01-8e73-dcf4d40775553
577033sildenafil 20 MG Oral TabletSCD5d19bb9a-c352-4e01-8e73-dcf4d40775553
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY5d19bb9a-c352-4e01-8e73-dcf4d40775553

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42543-005-10425430005101000 in 1 BOTTLEHistorical
42543-005-904254300059090 in 1 BOTTLEHistorical