FDA.reportPublic FDA data

SILDENAFIL CITRATE

Product NDC
51655-794
11-digit product format
516550794
Labeler code
51655
Product ID
51655-794_4a7b48ce-0f22-14dc-e063-6394a90a10a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA091448
Marketing category
ANDA
Marketing start
2022-01-20
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 CITRATE
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-794-54SILDENAFIL CITRATE15 in 1 BOTTLE, PLASTICTABLET, FILM COATED153
51655-794-87SILDENAFIL CITRATE6 in 1 BOTTLE, PLASTICTABLET, FILM COATED63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-794SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240727_d9de0817-cac1-4ee5-e053-2a95a90a5fa7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNd9de0817-cac1-4ee5-e053-2a95a90a5fa73
314229sildenafil 100 MG Oral TabletSCDd9de0817-cac1-4ee5-e053-2a95a90a5fa73
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYd9de0817-cac1-4ee5-e053-2a95a90a5fa73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-794-545165507945415 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-794-54) 2022-01-20NoNoHistorical
51655-794-87516550794876 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-794-87) 2022-01-20NoNoHistorical