FDA.reportPublic FDA data

Sildenafil Citrate

Product NDC
82804-025
11-digit product format
828040025
Labeler code
82804
Product ID
82804-025_b9b1d6ee-da42-4ef2-ab93-cd36d7f34150
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA206401
Marketing category
ANDA
Marketing start
2018-10-12
Substance
SILDENAFIL CITRATE
Active strength
100 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 Citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui314229

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
82804-025-30Sildenafil Citrate30 in 1 BOTTLETABLET, FILM COATED301
82804-025-60Sildenafil Citrate60 in 1 BOTTLETABLET, FILM COATED601
82804-025-90Sildenafil Citrate90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-025-30EA - Each82804-025af106709-2531-43be-bd13-fe5b10f05d6712024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-025SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, 3 package rows20231013_b9b1d6ee-da42-4ef2-ab93-cd36d7f34150.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNb9b1d6ee-da42-4ef2-ab93-cd36d7f341501
314229sildenafil 100 MG Oral TabletSCDb9b1d6ee-da42-4ef2-ab93-cd36d7f341501
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYb9b1d6ee-da42-4ef2-ab93-cd36d7f341501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-025-308280400253030 TABLET, FILM COATED in 1 BOTTLE (82804-025-30) 2023-10-12NoNoCurrent
82804-025-608280400256060 TABLET, FILM COATED in 1 BOTTLE (82804-025-60) 2023-10-12NoNoCurrent
82804-025-908280400259090 TABLET, FILM COATED in 1 BOTTLE (82804-025-90) 2023-10-12NoNoCurrent