FDA.reportPublic FDA data

Sildenafil

Product NDC
68071-2689
11-digit product format
680712689
Labeler code
68071
Product ID
68071-2689_de5a11ba-8487-dabc-e053-2a95a90ac0c1
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
25 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
68071-2689-32025-01-30C16284748780-12cef2736-ae26-d83d-e063-dadaa90ab31fThese 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
68071-2689-3Sildenafil30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2689SILDENAFIL TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20220507_de5a11ba-8486-dabc-e053-2a95a90ac0c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314228sildenafil citrate 25 MG Oral TabletPSNde5a11ba-8486-dabc-e053-2a95a90ac0c11
314228sildenafil 25 MG Oral TabletSCDde5a11ba-8486-dabc-e053-2a95a90ac0c11
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSYde5a11ba-8486-dabc-e053-2a95a90ac0c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2689-36807126890330 TABLET, FILM COATED in 1 BOTTLE (68071-2689-3) 2022-05-060000-00-00NoNoCurrent