Tadalafil

Product NDC
50436-7010
11-digit product format
504367010
Labeler code
50436
Product ID
50436-7010_0a804f42-1b9b-4ca4-bd81-83763c1b81a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
NDA021368
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-09-27
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
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
50436-7010-1Tadalafil200 in 1 CASETABLET, FILM COATED2004
50436-7010-1Tadalafil1 in 1 POUCHTABLET, FILM COATED14
50436-7010-2Tadalafil30 in 1 BOTTLETABLET, FILM COATED304
50436-7010-3Tadalafil90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-7010TADALAFIL TABLET, FILM COATED [UNIT DOSE SERVICES]4Legacy NDC, 4 package rows20190222_83040eb4-e541-499a-ae63-36534e31a94c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
757707tadalafil 2.5 MG Oral TabletPSN83040eb4-e541-499a-ae63-36534e31a94c4
403957tadalafil 5 MG Oral TabletPSN83040eb4-e541-499a-ae63-36534e31a94c4
757707tadalafil 2.5 MG Oral TabletSCD83040eb4-e541-499a-ae63-36534e31a94c4
403957tadalafil 5 MG Oral TabletSCD83040eb4-e541-499a-ae63-36534e31a94c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-7010-150436701001200 in 1 CASEHistorical
50436-7010-25043670100230 in 1 BOTTLEHistorical
50436-7010-35043670100390 in 1 BOTTLEHistorical