FDA.reportPublic FDA data

Sildenafil

Product NDC
53217-293
11-digit product format
532170293
Labeler code
53217
Product ID
53217-293_d7c2ba37-8904-4395-ac23-85d29efefe9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA203963
Marketing category
ANDA
Marketing start
2015-11-18
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
53217-293-102020-01-31C16284748780-19d75b9d0-d9a8-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 20 mg, for oral use Initial U.S. Approval: 1998
53217-293-902020-01-31C16284748780-19d75b9d0-d9a8-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 20 mg, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-293-10Sildenafil10 in 1 BOTTLETABLET, FILM COATED101
53217-293-90Sildenafil90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-293-10EA - Each53217-293a72fb64b-f53f-42a8-8852-11718630bfe412017-06-15
53217-293-90EA - Each53217-293fd6a2806-99e8-4078-b629-49b7b4262e5d12017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-293SILDENAFIL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20170511_c290dc6b-ecb6-4e5f-b45a-4b18217bf325.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNc290dc6b-ecb6-4e5f-b45a-4b18217bf3251
577033sildenafil 20 MG Oral TabletSCDc290dc6b-ecb6-4e5f-b45a-4b18217bf3251
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYc290dc6b-ecb6-4e5f-b45a-4b18217bf3251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-293-105321702931010 in 1 BOTTLEHistorical
53217-293-905321702939090 in 1 BOTTLEHistorical