Sildenafil Citrate

Product NDC
80425-0410
11-digit product format
804250410
Labeler code
80425
Product ID
80425-0410_1ceb66c5-0d49-0ab1-e063-6294a90a83d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA206401
Marketing category
ANDA
Marketing start
2024-07-10
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ac996ae9-22a2-41c2-bb86-913c4aef95adProduct name120230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fcProduct name920220613

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0410-1Sildenafil Citrate6 in 1 BOTTLETABLET, FILM COATED61
80425-0410-2Sildenafil Citrate12 in 1 BOTTLETABLET, FILM COATED121
80425-0410-3Sildenafil Citrate30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0410-1EA - Each80425-04107ad18119-3d89-48b8-975c-8d406b4c5ef912024-08-12
80425-0410-2EA - Each80425-041025d083a0-dc61-4b3c-9849-da509cb23b6212024-08-12
80425-0410-3EA - Each80425-04105117dba3-50be-4bae-a43b-2deb99f8707612024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0410SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20240711_1ceb575b-2687-0456-e063-6394a90aa88a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN1ceb575b-2687-0456-e063-6394a90aa88a1
314229sildenafil 100 MG Oral TabletSCD1ceb575b-2687-0456-e063-6394a90aa88a1
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY1ceb575b-2687-0456-e063-6394a90aa88a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0410-1804250410016 TABLET, FILM COATED in 1 BOTTLE (80425-0410-1) 2024-07-10NoNoHistorical
80425-0410-28042504100212 TABLET, FILM COATED in 1 BOTTLE (80425-0410-2) 2024-07-10NoNoHistorical
80425-0410-38042504100330 TABLET, FILM COATED in 1 BOTTLE (80425-0410-3) 2024-07-10NoNoHistorical