FDA.reportPublic FDA data

Sildenafil

Product NDC
51655-172
11-digit product format
516550172
Labeler code
51655
Product ID
51655-172_48c3f84b-f73b-78b6-e063-6394a90abf6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA202025
Marketing category
ANDA
Marketing start
2023-04-19
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
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-172-20Sildenafil20 in 1 BOTTLE, PLASTICTABLET203
51655-172-52Sildenafil30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-172SILDENAFIL TABLET [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240713_fa14cb6b-0fa8-0ba0-e053-6294a90afae3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNfa14cb6b-0fa8-0ba0-e053-6294a90afae33
577033sildenafil 20 MG Oral TabletSCDfa14cb6b-0fa8-0ba0-e053-6294a90afae33
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYfa14cb6b-0fa8-0ba0-e053-6294a90afae33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-172-205165501722020 TABLET in 1 BOTTLE, PLASTIC (51655-172-20) 20 tablet2023-04-19NoNoHistorical
51655-172-525165501725230 TABLET in 1 BOTTLE, PLASTIC (51655-172-52) 30 tablet2023-04-19NoNoHistorical