Sildenafil

Product NDC
42291-937
11-digit product format
422910937
Labeler code
42291
Product ID
42291-937_48c0e47e-08b2-0c73-e063-6394a90a90b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA202025
Marketing category
ANDA
Marketing start
2024-09-10
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
42291-937-90Sildenafil90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-937-90EA - Each42291-937d4d3c6e2-29e9-4369-8f23-a8c8a2d6be4f12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-937SILDENAFIL TABLET [AVKARE]1Current NDC, 1 package rows20240912_21c83ff3-c359-3269-e063-6394a90a57ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN21c83ff3-c359-3269-e063-6394a90a57ee2
577033sildenafil 20 MG Oral TabletSCD21c83ff3-c359-3269-e063-6394a90a57ee2
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY21c83ff3-c359-3269-e063-6394a90a57ee2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42291-937-904229109379090 TABLET in 1 BOTTLE (42291-937-90) 90 tablet2024-09-10NoNoCurrent