FDA.reportPublic FDA data

Sildenafil

Product NDC
68788-7974
11-digit product format
687887974
Labeler code
68788
Product ID
68788-7974_6bea9b0c-7b49-46f6-abf7-0cfb2c582103
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA210394
Marketing category
ANDA
Marketing start
2021-07-28
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
68788-7974-3Sildenafil30 in 1 BOTTLETABLET304
68788-7974-4Sildenafil4 in 1 BOTTLETABLET44
68788-7974-6Sildenafil60 in 1 BOTTLETABLET604
68788-7974-9Sildenafil90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7974-3EA - Each68788-7974ddceac83-3930-4985-9588-76a24e77263c12021-09-07
68788-7974-4EA - Each68788-7974593ad8b6-2bf3-4412-af80-78b7c81e635712021-09-07
68788-7974-6EA - Each68788-79740adf1570-9b83-4743-8a45-ecf69a3e449412021-09-07
68788-7974-9EA - Each68788-7974f49181dd-65e6-41bd-a94e-4d89e0df4b0612021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7974SILDENAFIL TABLET [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 4 package rows20250119_d887377e-90c5-44dc-8455-b23a6755b36f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNd887377e-90c5-44dc-8455-b23a6755b36f4
577033sildenafil 20 MG Oral TabletSCDd887377e-90c5-44dc-8455-b23a6755b36f4
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYd887377e-90c5-44dc-8455-b23a6755b36f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7974-36878879740330 TABLET in 1 BOTTLE (68788-7974-3) 30 tablet2021-07-280000-00-00NoNoCurrent
68788-7974-4687887974044 TABLET in 1 BOTTLE (68788-7974-4) 4 tablet2021-07-280000-00-00NoNoCurrent
68788-7974-66878879740660 TABLET in 1 BOTTLE (68788-7974-6) 60 tablet2021-07-280000-00-00NoNoCurrent
68788-7974-96878879740990 TABLET in 1 BOTTLE (68788-7974-9) 90 tablet2021-07-280000-00-00NoNoCurrent