FDA.reportPublic FDA data

Sildenafil

Product NDC
82647-211
11-digit product format
826470211
Labeler code
82647
Product ID
82647-211_49fd0cc5-980e-c7d1-e063-6394a90a85c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Reyoung Corporation
Application
ANDA208494
Marketing category
ANDA
Marketing start
2022-03-28
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sildenafil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui312950, 314228, 314229

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
82647-211-142024-04-15C16284748780-11030e365-36e9-111a-e063-dadaa90a10e2These 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
82647-211-302024-04-15C16284748780-11030e365-36e9-111a-e063-dadaa90a10e2These 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
82647-211-142024-01-30C16284748780-11030e365-36e9-111a-e063-dadaa90a10e2These 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
82647-211-302024-01-30C16284748780-11030e365-36e9-111a-e063-dadaa90a10e2These 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
82647-211-14Sildenafil1000 in 1 BOTTLETABLET, FILM COATED10003
82647-211-30Sildenafil30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82647-211SILDENAFIL TABLET, FILM COATED [REYOUNG CORPORATION]2Current NDC, Legacy NDC, 2 package rows20240417_dc998a9c-0770-111b-e053-2a95a90a88a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNdc998a9c-0770-111b-e053-2a95a90a88a43
314228sildenafil citrate 25 MG Oral TabletPSNdc998a9c-0770-111b-e053-2a95a90a88a43
312950sildenafil citrate 50 MG Oral TabletPSNdc998a9c-0770-111b-e053-2a95a90a88a43
314229sildenafil 100 MG Oral TabletSCDdc998a9c-0770-111b-e053-2a95a90a88a43
314228sildenafil 25 MG Oral TabletSCDdc998a9c-0770-111b-e053-2a95a90a88a43
312950sildenafil 50 MG Oral TabletSCDdc998a9c-0770-111b-e053-2a95a90a88a43
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYdc998a9c-0770-111b-e053-2a95a90a88a43
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSYdc998a9c-0770-111b-e053-2a95a90a88a43
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYdc998a9c-0770-111b-e053-2a95a90a88a43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82647-211-14826470211141000 TABLET, FILM COATED in 1 BOTTLE (82647-211-14) 2022-03-280000-00-00NoNoCurrent
82647-211-308264702113030 TABLET, FILM COATED in 1 BOTTLE (82647-211-30) 2022-03-280000-00-00NoNoCurrent