SILDENAFIL

Product NDC
55154-4307
11-digit product format
551544307
Labeler code
55154
Product ID
55154-4307_2992b7db-d287-4d97-9c90-1961a7b4eaba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA091479
Marketing category
ANDA
Marketing start
2012-11-06
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
55154-4307-0SILDENAFIL1 in 1 BLISTER PACKTABLET, FILM COATED15
55154-4307-0SILDENAFIL10 in 1 BAGTABLET, FILM COATED105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4307SILDENAFIL TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]4Current NDC, 2 package rows20250504_c5ac2265-393a-4fbe-b974-1dd0b9243ec8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNc5ac2265-393a-4fbe-b974-1dd0b9243ec85
577033sildenafil 20 MG Oral TabletSCDc5ac2265-393a-4fbe-b974-1dd0b9243ec85
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYc5ac2265-393a-4fbe-b974-1dd0b9243ec85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-4307-05515443070010 BLISTER PACK in 1 BAG (55154-4307-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2012-11-06NoNoHistorical