FDA.reportPublic FDA data

SILDENAFIL

Product NDC
51655-131
11-digit product format
516550131
Labeler code
51655
Product ID
51655-131_6c9ee14a-df87-4ebb-afc8-f717529ed4f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Pharmaceuticals, LLC
Application
ANDA091479
Marketing category
ANDA
Marketing start
2014-11-06
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
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-131-202026-01-02C16284748780-19d75b9d0-64f9-f424-e053-dadaa90a57cee06f3f68-3635-4fc0-b4d0-5ea46c0582ff
51655-131-532026-01-02C16284748780-19d75b9d0-64f9-f424-e053-dadaa90a57cee06f3f68-3635-4fc0-b4d0-5ea46c0582ff
51655-131-202020-01-31C16284748780-19d75b9d0-64f9-f424-e053-dadaa90a57cee06f3f68-3635-4fc0-b4d0-5ea46c0582ff
51655-131-532020-01-31C16284748780-19d75b9d0-64f9-f424-e053-dadaa90a57cee06f3f68-3635-4fc0-b4d0-5ea46c0582ff

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SILDENAFIL CITRATEACTIVE INGREDIENTBW9B0ZE037SILDENAFIL TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1
SILDENAFILACTIVE MOIETY3M7OB98Y7HSILDENAFIL TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-131SILDENAFIL TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1Legacy NDC20141106_e06f3f68-3635-4fc0-b4d0-5ea46c0582ff.zip