Sildenafil

Product NDC
82804-243
11-digit product format
828040243
Labeler code
82804
Product ID
82804-243_71140bd5-0a51-4c01-ad0d-193d08ea67dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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
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
82804-243-30Sildenafil30 in 1 BOTTLETABLET, FILM COATED301
82804-243-90Sildenafil90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-243-30EA - Each82804-243b3d58407-1755-4c52-a81f-b98e61d4be0b12026-02-05
82804-243-90EA - Each82804-24387fe5125-8467-4ba5-ae40-218c2fd4184c12026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN71140bd5-0a51-4c01-ad0d-193d08ea67dd1
577033sildenafil 20 MG Oral TabletSCD71140bd5-0a51-4c01-ad0d-193d08ea67dd1
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY71140bd5-0a51-4c01-ad0d-193d08ea67dd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-243-308280402433030 TABLET, FILM COATED in 1 BOTTLE (82804-243-30) 2025-09-10NoNoCurrent
82804-243-908280402439090 TABLET, FILM COATED in 1 BOTTLE (82804-243-90) 2025-09-15NoNoCurrent