Sildenafil

Product NDC
53217-198
11-digit product format
532170198
Labeler code
53217
Product ID
53217-198_71c6953c-6472-4610-a4ea-5f868b2ed3ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA203623
Marketing category
ANDA
Marketing start
2014-11-26
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-198-10Sildenafil10 in 1 BOTTLETABLET, FILM COATED101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-198SILDENAFIL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20170302_67dad779-06e6-4cba-bdad-2ea38be65f04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN67dad779-06e6-4cba-bdad-2ea38be65f041
577033sildenafil 20 MG Oral TabletSCD67dad779-06e6-4cba-bdad-2ea38be65f041
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY67dad779-06e6-4cba-bdad-2ea38be65f041

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-198-105321701981010 in 1 BOTTLEHistorical