FDA.reportPublic FDA data

Tadalafil

Product NDC
33342-278
11-digit product format
333420278
Labeler code
33342
Product ID
33342-278_8b7e0bf0-c13c-4d67-ba78-68fc6ef8b9b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA207290
Marketing category
ANDA
Marketing start
2019-10-17
Substance
TADALAFIL
Active strength
20 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
TADALAFIL20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii742SXX0ICT
Rxcui2123194

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-278-07Tadalafil30 in 1 BOTTLETABLET, FILM COATED303
33342-278-09Tadalafil60 in 1 BOTTLETABLET, FILM COATED603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-278TADALAFIL TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3Current NDC, Legacy NDC, 2 package rows20221001_93dd604f-8f38-4600-afe8-0fcc92fd2497.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123194tadalafil 20 MG Pulmonary Hypertension Oral TabletPSN93dd604f-8f38-4600-afe8-0fcc92fd24973
2123194Pulmonary Hypertension tadalafil 20 MG Oral TabletSCD93dd604f-8f38-4600-afe8-0fcc92fd24973
2123194tadalafil 20 MG Pulmonary Hypertension Oral TabletSY93dd604f-8f38-4600-afe8-0fcc92fd24973

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
33342-278-073334202780730 TABLET, FILM COATED in 1 BOTTLE (33342-278-07) 2019-10-300000-00-00NoNoCurrent
33342-278-093334202780960 TABLET, FILM COATED in 1 BOTTLE (33342-278-09) 2019-10-300000-00-00NoNoCurrent