Tadalafil

Product NDC
50436-6460
11-digit product format
504366460
Labeler code
50436
Product ID
50436-6460_4fb24338-4ba7-4f24-8f94-bea159aec203
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA209908
Marketing category
ANDA
Marketing start
2019-03-26
Marketing end
0000-00-00
Substance
TADALAFIL
Active strength
20 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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
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
50436-6460-1Tadalafil1 in 1 POUCHTABLET, FILM COATED16
50436-6460-1Tadalafil1350 in 1 CASETABLET, FILM COATED13506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-6460TADALAFIL TABLET, FILM COATED [UNIT DOSE SERVICES]6Legacy NDC, 2 package rows20191127_25ac4403-8094-488a-a49a-f7210a664beb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSN25ac4403-8094-488a-a49a-f7210a664beb6
402019tadalafil 20 MG Oral TabletPSN25ac4403-8094-488a-a49a-f7210a664beb6
403957tadalafil 5 MG Oral TabletPSN25ac4403-8094-488a-a49a-f7210a664beb6
484814tadalafil 10 MG Oral TabletSCD25ac4403-8094-488a-a49a-f7210a664beb6
402019tadalafil 20 MG Oral TabletSCD25ac4403-8094-488a-a49a-f7210a664beb6
403957tadalafil 5 MG Oral TabletSCD25ac4403-8094-488a-a49a-f7210a664beb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-6460-1504366460011 in 1 POUCHHistorical