Tadalafil

Product NDC
50090-4753
11-digit product format
500904753
Labeler code
50090
Product ID
50090-4753_40ee1c1c-fc3c-4ad2-9f1d-992b1b0fec3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA206693
Marketing category
ANDA
Marketing start
2019-03-27
Marketing end
0000-00-00
Substance
TADALAFIL
Active strength
5 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4753-0Tadalafil90 in 1 BOTTLETABLET, FILM COATED903
50090-4753-1Tadalafil30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4753TADALAFIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20210303_13e72ff9-29bd-4aa4-ba24-0aafa7dacd7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403957tadalafil 5 MG Oral TabletPSN13e72ff9-29bd-4aa4-ba24-0aafa7dacd7e3
403957tadalafil 5 MG Oral TabletSCD13e72ff9-29bd-4aa4-ba24-0aafa7dacd7e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4753-05009047530090 TABLET, FILM COATED in 1 BOTTLE (50090-4753-0) 2019-11-260000-00-00NoNoCurrent
50090-4753-15009047530130 TABLET, FILM COATED in 1 BOTTLE (50090-4753-1) 2020-05-080000-00-00NoNoCurrent