Sildenafil

Product NDC
82804-185
11-digit product format
828040185
Labeler code
82804
Product ID
82804-185_3c68969c-9034-4913-8ba1-5b0a43234ead
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA210394
Marketing category
ANDA
Marketing start
2018-05-04
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
82804-185-30Sildenafil30 in 1 BOTTLETABLET302
82804-185-90Sildenafil90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-185SILDENAFIL TABLET [PROFICIENT RX LP]1Current NDC, 2 package rows20250221_7dd302cd-b84d-4d7d-bd1e-2916febbaea5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN7dd302cd-b84d-4d7d-bd1e-2916febbaea52
577033sildenafil 20 MG Oral TabletSCD7dd302cd-b84d-4d7d-bd1e-2916febbaea52
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY7dd302cd-b84d-4d7d-bd1e-2916febbaea52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-185-308280401853030 TABLET in 1 BOTTLE (82804-185-30) 30 tablet2025-08-06NoNoCurrent
82804-185-908280401859090 TABLET in 1 BOTTLE (82804-185-90) 90 tablet2025-02-06NoNoCurrent