FDA.reportPublic FDA data

Sildenafil

Product NDC
76420-061
11-digit product format
764200061
Labeler code
76420
Product ID
76420-061_e785ec65-b5e8-693c-e053-2995a90aa9e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA203814
Marketing category
ANDA
Marketing start
2014-01-03
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sildenafil
Listing expiration
2026-12-31

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
76420-061-30Sildenafil30 in 1 BOTTLETABLET, FILM COATED302
76420-061-60Sildenafil60 in 1 BOTTLETABLET, FILM COATED602
76420-061-90Sildenafil90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-061SILDENAFIL TABLET, FILM COATED [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 3 package rows20220902_06571775-b651-4e23-a35b-88392aae7e13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN06571775-b651-4e23-a35b-88392aae7e132
577033sildenafil 20 MG Oral TabletSCD06571775-b651-4e23-a35b-88392aae7e132
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY06571775-b651-4e23-a35b-88392aae7e132

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76420-061-307642000613030 TABLET, FILM COATED in 1 BOTTLE (76420-061-30) 2019-12-100000-00-00NoNoCurrent
76420-061-607642000616060 TABLET, FILM COATED in 1 BOTTLE (76420-061-60) 2022-08-310000-00-00NoNoCurrent
76420-061-907642000619090 TABLET, FILM COATED in 1 BOTTLE (76420-061-90) 2019-12-100000-00-00NoNoCurrent