SILDENAFIL

Product NDC
50090-6804
11-digit product format
500906804
Labeler code
50090
Product ID
50090-6804_fe1514c6-f229-46ee-b92d-90f2f3981cce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204882
Marketing category
ANDA
Marketing start
2021-06-17
Substance
SILDENAFIL CITRATE
Active strength
50 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 CITRATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui312950

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
50090-6804-0SILDENAFIL10 in 1 BOTTLETABLET, FILM COATED105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6804-0EA - Each50090-680473cbe167-f133-47b4-a80d-64f5569fdc3412023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6804SILDENAFIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Current NDC, 1 package rows20241023_e5ad3ce5-29ee-4b55-a67a-0f28c23a3afa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312950sildenafil citrate 50 MG Oral TabletPSNe5ad3ce5-29ee-4b55-a67a-0f28c23a3afa5
312950sildenafil 50 MG Oral TabletSCDe5ad3ce5-29ee-4b55-a67a-0f28c23a3afa5
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYe5ad3ce5-29ee-4b55-a67a-0f28c23a3afa5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6804-05009068040010 TABLET, FILM COATED in 1 BOTTLE (50090-6804-0) 2023-11-06NoNoHistorical