FDA.reportPublic FDA data

Tadalafil

Product NDC
33342-266
11-digit product format
333420266
Labeler code
33342
Product ID
33342-266_1bc04765-18de-40fc-a680-fbe55aad1cf2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA207244
Marketing category
ANDA
Marketing start
2019-10-08
Substance
TADALAFIL
Active strength
5 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
TADALAFIL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii742SXX0ICT
Rxcui402019, 403957, 484814, 757707

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
33342-266-07Tadalafil30 in 1 BOTTLETABLET, FILM COATED304
33342-266-44Tadalafil1000 in 1 BOTTLETABLET, FILM COATED10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-266-07EA - Each33342-2661d148359-4a06-46c0-8f32-a90cd348fcf712020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-266TADALAFIL TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3Current NDC, Legacy NDC, 2 package rows20250323_4348b7db-e5b2-4e87-8cdd-674797a18890.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSN4348b7db-e5b2-4e87-8cdd-674797a188904
757707tadalafil 2.5 MG Oral TabletPSN4348b7db-e5b2-4e87-8cdd-674797a188904
402019tadalafil 20 MG Oral TabletPSN4348b7db-e5b2-4e87-8cdd-674797a188904
403957tadalafil 5 MG Oral TabletPSN4348b7db-e5b2-4e87-8cdd-674797a188904
484814tadalafil 10 MG Oral TabletSCD4348b7db-e5b2-4e87-8cdd-674797a188904
757707tadalafil 2.5 MG Oral TabletSCD4348b7db-e5b2-4e87-8cdd-674797a188904
402019tadalafil 20 MG Oral TabletSCD4348b7db-e5b2-4e87-8cdd-674797a188904
403957tadalafil 5 MG Oral TabletSCD4348b7db-e5b2-4e87-8cdd-674797a188904
403957tadalafil 5 MG Oral TabletPSNdce8155e-b8b3-4c5b-8b8c-47c0052036c62
403957tadalafil 5 MG Oral TabletSCDdce8155e-b8b3-4c5b-8b8c-47c0052036c62
403957tadalafil 5 MG Oral TabletPSN2121cd9b-a2c0-4f19-a33d-939c6fb3826d1
403957tadalafil 5 MG Oral TabletPSN51f87c9b-038c-4793-b0d5-5359ae2310741
403957tadalafil 5 MG Oral TabletSCD2121cd9b-a2c0-4f19-a33d-939c6fb3826d1
403957tadalafil 5 MG Oral TabletSCD51f87c9b-038c-4793-b0d5-5359ae2310741

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
33342-266-073334202660730 TABLET, FILM COATED in 1 BOTTLE (33342-266-07) 2019-10-080000-00-00NoNoCurrent
33342-266-44333420266441000 TABLET, FILM COATED in 1 BOTTLE (33342-266-44) 2025-04-17NoNoHistorical