FDA.reportPublic FDA data

Sildenafil

Product NDC
68071-2072
11-digit product format
680712072
Labeler code
68071
Product ID
68071-2072_1d609fda-9b9d-40b3-e063-6294a90a63b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA203814
Marketing category
ANDA
Marketing start
2014-01-03
Marketing end
2027-10-31
Substance
SILDENAFIL CITRATE
Active strength
20 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sildenafil

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui577033

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
68071-2072-12024-08-20C16284748780-1ba0f9c33-311d-a910-e053-dadaa90a0b85These 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
68071-2072-22024-08-20C16284748780-1ba0f9c33-311d-a910-e053-dadaa90a0b85These 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
68071-2072-42024-08-20C16284748780-1ba0f9c33-311d-a910-e053-dadaa90a0b85These 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
68071-2072-52024-08-20C16284748780-1ba0f9c33-311d-a910-e053-dadaa90a0b85These 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
68071-2072-12023-01-30C16284748780-1ba0f9c33-311d-a910-e053-dadaa90a0b85These 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
68071-2072-22023-01-30C16284748780-1ba0f9c33-311d-a910-e053-dadaa90a0b85These 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
68071-2072-42023-01-30C16284748780-1ba0f9c33-311d-a910-e053-dadaa90a0b85These 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
68071-2072-52023-01-30C16284748780-1ba0f9c33-311d-a910-e053-dadaa90a0b85These 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
68071-2072-12021-02-23C16284748780-1ba0f9c33-311d-a910-e053-dadaa90a0b85These 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
68071-2072-22021-02-23C16284748780-1ba0f9c33-311d-a910-e053-dadaa90a0b85These 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
68071-2072-42021-02-23C16284748780-1ba0f9c33-311d-a910-e053-dadaa90a0b85These 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
68071-2072-52021-02-23C16284748780-1ba0f9c33-311d-a910-e053-dadaa90a0b85These 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
68071-2072-12021-01-29C16284748780-1ba0f9c33-311d-a910-e053-dadaa90a0b85These 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
68071-2072-22021-01-29C16284748780-1ba0f9c33-311d-a910-e053-dadaa90a0b85These 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
68071-2072-42021-01-29C16284748780-1ba0f9c33-311d-a910-e053-dadaa90a0b85These 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
68071-2072-52021-01-29C16284748780-1ba0f9c33-311d-a910-e053-dadaa90a0b85These 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
68071-2072-1Sildenafil10 in 1 BOTTLETABLET, FILM COATED108
68071-2072-2Sildenafil28 in 1 BOTTLETABLET, FILM COATED288
68071-2072-4Sildenafil4 in 1 BOTTLETABLET, FILM COATED48
68071-2072-5Sildenafil20 in 1 BOTTLETABLET, FILM COATED208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68071-2072-1EA - Each68071-2072e0471f01-57bb-4b1c-9c26-5d3a03666ba412017-03-06
68071-2072-2EA - Each68071-2072c3cc4da9-b4a1-40a1-a4f2-fb9233296bb312017-03-06
68071-2072-4EA - Each68071-2072fb25a106-f922-478f-8022-62a2f1ce372a12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2072SILDENAFIL TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 4 package rows20240822_46dff4c0-9a6c-20f9-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN46dff4c0-9a6c-20f9-e054-00144ff8d46c8
577033sildenafil 20 MG Oral TabletSCD46dff4c0-9a6c-20f9-e054-00144ff8d46c8
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY46dff4c0-9a6c-20f9-e054-00144ff8d46c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2072-16807120720110 TABLET, FILM COATED in 1 BOTTLE (68071-2072-1) 2017-01-242027-10-31NoNoCurrent
68071-2072-26807120720228 TABLET, FILM COATED in 1 BOTTLE (68071-2072-2) 2017-01-242027-10-31NoNoCurrent
68071-2072-4680712072044 TABLET, FILM COATED in 1 BOTTLE (68071-2072-4) 2017-01-242027-10-31NoNoCurrent
68071-2072-56807120720520 TABLET, FILM COATED in 1 BOTTLE (68071-2072-5) 2017-01-242027-10-31NoNoCurrent