Tadalafil

Product NDC
50090-7391
11-digit product format
500907391
Labeler code
50090
Product ID
50090-7391_fc7389ad-d070-4f61-a6ce-e1e21b78e212
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208934
Marketing category
ANDA
Marketing start
2020-02-19
Substance
TADALAFIL
Active strength
5 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
Tadalafil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TADALAFIL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii742SXX0ICT
Rxcui403957

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b90b74cb-f6c8-3798-d11c-73b8768b278aProduct name820250317
0fe0157c-95a7-4870-ae64-de9f3fa874aeProduct name120250227
20ae0006-d78c-4dba-9e3e-6ae424841903Product name120250127
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b86a08b7-54cc-440b-ad4a-3e530ccd8324Product name620230421
7a02e74a-2844-42af-84a8-96bae57351cfProduct name120230313
928d249c-35c3-4d88-a9ef-cf2f2e31b96fProduct name120220706

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7391-0Tadalafil90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7391-0EA - Each50090-7391093b53bd-ae34-41d2-b7a8-49b673c2bfd012024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7391TADALAFIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20241027_1580ab76-e229-4b8d-8c7b-82f39fecfebd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403957tadalafil 5 MG Oral TabletPSN1580ab76-e229-4b8d-8c7b-82f39fecfebd1
403957tadalafil 5 MG Oral TabletSCD1580ab76-e229-4b8d-8c7b-82f39fecfebd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7391-05009073910090 TABLET, FILM COATED in 1 BOTTLE (50090-7391-0) 2024-10-23NoNoHistorical