FDA.reportPublic FDA data

Sildenafil Citrate

Product NDC
51655-793
11-digit product format
516550793
Labeler code
51655
Product ID
51655-793_4973b481-9749-d08d-e063-6294a90a4ee7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA204883
Marketing category
ANDA
Marketing start
2022-01-20
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 Citrate
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
51655-793-20Sildenafil Citrate20 in 1 BOTTLE, PLASTICTABLET, FILM COATED202
51655-793-52Sildenafil Citrate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-793SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]1Current NDC, 2 package rows20230221_d9ddfd2a-1961-90f9-e053-2a95a90a7f9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNd9ddfd2a-1961-90f9-e053-2a95a90a7f9b2
577033sildenafil 20 MG Oral TabletSCDd9ddfd2a-1961-90f9-e053-2a95a90a7f9b2
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYd9ddfd2a-1961-90f9-e053-2a95a90a7f9b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-793-205165507932020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-793-20) 2022-01-20NoNoHistorical
51655-793-525165507935230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-793-52) 2022-01-20NoNoHistorical