FDA.reportPublic FDA data

Sildenafil Citrate

Product NDC
17856-8100
11-digit product format
178568100
Labeler code
17856
Product ID
17856-8100_948b14c0-62f6-423f-a718-7bee707ed00c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA204883
Marketing category
ANDA
Marketing start
2019-07-29
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
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
17856-8100-12023-01-30C16284748780-1f386c649-a0fa-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
17856-8100-22023-01-30C16284748780-1f386c649-a0fa-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
17856-8100-32023-01-30C16284748780-1f386c649-a0fa-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
17856-8100-42023-01-30C16284748780-1f386c649-a0fa-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
17856-8100-52023-01-30C16284748780-1f386c649-a0fa-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
17856-8100-1Sildenafil Citrate1 in 1 POUCHTABLET, FILM COATED12
17856-8100-1Sildenafil Citrate200 in 1 BOXTABLET, FILM COATED2002
17856-8100-2Sildenafil Citrate200 in 1 BOXTABLET, FILM COATED2002
17856-8100-2Sildenafil Citrate2 in 1 POUCHTABLET, FILM COATED22
17856-8100-3Sildenafil Citrate3 in 1 POUCHTABLET, FILM COATED32
17856-8100-3Sildenafil Citrate200 in 1 BOXTABLET, FILM COATED2002
17856-8100-4Sildenafil Citrate4 in 1 POUCHTABLET, FILM COATED42
17856-8100-4Sildenafil Citrate200 in 1 BOXTABLET, FILM COATED2002
17856-8100-5Sildenafil Citrate5 in 1 POUCHTABLET, FILM COATED52
17856-8100-5Sildenafil Citrate200 in 1 BOXTABLET, FILM COATED2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-8100SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [ATLANTIC BIOLOGICALS CORP.]2Legacy NDC, 10 package rows20210121_f0fc8f9c-7173-4d51-a39a-49437e7e73ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNf0fc8f9c-7173-4d51-a39a-49437e7e73ee2
577033sildenafil 20 MG Oral TabletSCDf0fc8f9c-7173-4d51-a39a-49437e7e73ee2
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYf0fc8f9c-7173-4d51-a39a-49437e7e73ee2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-8100-117856810001200 POUCH in 1 BOX (17856-8100-1) > 1 TABLET, FILM COATED in 1 POUCH200 pouch2021-01-200000-00-00NoNoCurrent
17856-8100-217856810002200 POUCH in 1 BOX (17856-8100-2) > 2 TABLET, FILM COATED in 1 POUCH200 pouch2021-01-200000-00-00NoNoCurrent
17856-8100-317856810003200 POUCH in 1 BOX (17856-8100-3) > 3 TABLET, FILM COATED in 1 POUCH200 pouch2021-01-200000-00-00NoNoCurrent
17856-8100-417856810004200 POUCH in 1 BOX (17856-8100-4) > 4 TABLET, FILM COATED in 1 POUCH200 pouch2021-01-200000-00-00NoNoCurrent
17856-8100-517856810005200 POUCH in 1 BOX (17856-8100-5) > 5 TABLET, FILM COATED in 1 POUCH200 pouch2021-01-200000-00-00NoNoCurrent