FDA.reportPublic FDA data

Tadalafil

Product NDC
70934-473
11-digit product format
709340473
Labeler code
70934
Product ID
70934-473_aef788fd-423d-6fd6-e053-2995a90a177f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Denton Pharma, Inc. dba Northwind Pharmaceuticals
Application
ANDA209539
Marketing category
ANDA
Marketing start
2019-12-05
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
2021-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-473-062022-01-28C16284748780-1d6a99b39-8126-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval:2003
70934-473-152022-01-28C16284748780-1d6a99b39-8126-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval:2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-473-06Tadalafil6 in 1 BOTTLE, PLASTICTABLET, FILM COATED62
70934-473-15Tadalafil15 in 1 BOTTLE, PLASTICTABLET, FILM COATED152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-473TADALAFIL TABLET, FILM COATED [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]2Legacy NDC, 2 package rows20201224_995b1a68-cee4-243f-e053-2995a90a6275.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402019tadalafil 20 MG Oral TabletPSN995b1a68-cee4-243f-e053-2995a90a62752
402019tadalafil 20 MG Oral TabletSCD995b1a68-cee4-243f-e053-2995a90a62752

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-473-06709340473066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-473-06) 2019-12-050000-00-00NoNoCurrent
70934-473-157093404731515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-473-15) 2019-12-050000-00-00NoNoCurrent