FDA.reportPublic FDA data

Sildenafil

Product NDC
51655-468
11-digit product format
516550468
Labeler code
51655
Product ID
51655-468_490f11b5-2d18-a878-e063-6394a90a8128
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA202659
Marketing category
ANDA
Marketing start
2020-11-06
Substance
SILDENAFIL CITRATE
Active strength
100 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 CITRATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui314229

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
51655-468-542026-01-29C16284748780-149896155-b0ec-586f-e063-e6dba90add90These 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
51655-468-872026-01-29C16284748780-149896155-b0ec-586f-e063-e6dba90add90These 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
51655-468-54Sildenafil15 in 1 BOTTLE, PLASTICTABLET, FILM COATED152
51655-468-87Sildenafil6 in 1 BOTTLE, PLASTICTABLET, FILM COATED62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-468SILDENAFIL TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 2 package rows20230328_f3089ee6-190d-4749-e053-2a95a90a15d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNf3089ee6-190d-4749-e053-2a95a90a15d82
314229sildenafil 100 MG Oral TabletSCDf3089ee6-190d-4749-e053-2a95a90a15d82
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYf3089ee6-190d-4749-e053-2a95a90a15d82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-468-545165504685415 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-468-54) 2020-11-06NoNoCurrent
51655-468-87516550468876 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-468-87) 2020-11-06NoNoCurrent