FDA.reportPublic FDA data

Sildenafil

Product NDC
68071-2552
11-digit product format
680712552
Labeler code
68071
Product ID
68071-2552_cf34515e-f20f-ceed-e053-2995a90a15a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA202659
Marketing category
ANDA
Marketing start
2018-06-11
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
2022-12-31
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
68071-2552-52025-01-30C16284748780-1f386c649-aad8-0266-e053-dadaa90a7c1aThese 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
68071-2552-52023-07-17C16284748780-1f386c649-aad8-0266-e053-dadaa90a7c1aThese 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
68071-2552-52023-01-30C16284748780-1f386c649-aad8-0266-e053-dadaa90a7c1aThese 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
68071-2552-5Sildenafil15 in 1 BOTTLETABLET, FILM COATED152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2552SILDENAFIL TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 1 package rows20230718_cf34447b-214b-2e11-e053-2a95a90a5fcc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312950sildenafil citrate 50 MG Oral TabletPSNcf34447b-214b-2e11-e053-2a95a90a5fcc2
312950sildenafil 50 MG Oral TabletSCDcf34447b-214b-2e11-e053-2a95a90a5fcc2
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYcf34447b-214b-2e11-e053-2a95a90a5fcc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2552-56807125520515 TABLET, FILM COATED in 1 BOTTLE (68071-2552-5) 2021-10-250000-00-00NoNoCurrent