FDA.reportPublic FDA data

tadalafil

Product NDC
76420-854
11-digit product format
764200854
Labeler code
76420
Product ID
76420-854_38689a7c-8af1-e4b0-e063-6394a90a94d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA209250
Marketing category
ANDA
Marketing start
2019-03-26
Substance
TADALAFIL
Active strength
2.5 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
TADALAFIL2.5 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-854-01tadalafil100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1002
76420-854-05tadalafil500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5002
76420-854-30tadalafil30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
76420-854-33tadalafil2 in 1 CARTONTABLET, FILM COATED22
76420-854-33tadalafil15 in 1 BLISTER PACKTABLET, FILM COATED152
76420-854-60tadalafil60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602
76420-854-90tadalafil90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-854TADALAFIL TABLET, FILM COATED [ASCLEMED USA, INC.]1Current NDC, 7 package rows20250131_fa547e3d-455a-4926-9fd9-349930898502.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSNfa547e3d-455a-4926-9fd9-3499308985022
757707tadalafil 2.5 MG Oral TabletPSNfa547e3d-455a-4926-9fd9-3499308985022
402019tadalafil 20 MG Oral TabletPSNfa547e3d-455a-4926-9fd9-3499308985022
403957tadalafil 5 MG Oral TabletPSNfa547e3d-455a-4926-9fd9-3499308985022
484814tadalafil 10 MG Oral TabletSCDfa547e3d-455a-4926-9fd9-3499308985022
757707tadalafil 2.5 MG Oral TabletSCDfa547e3d-455a-4926-9fd9-3499308985022
402019tadalafil 20 MG Oral TabletSCDfa547e3d-455a-4926-9fd9-3499308985022
403957tadalafil 5 MG Oral TabletSCDfa547e3d-455a-4926-9fd9-3499308985022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-854-0176420085401100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-854-01) 2025-01-28NoNoHistorical
76420-854-0576420085405500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-854-05) 2025-01-28NoNoHistorical
76420-854-307642008543030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-854-30) 2025-01-28NoNoHistorical
76420-854-33764200854332 BLISTER PACK in 1 CARTON (76420-854-33) / 15 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2025-01-28NoNoHistorical
76420-854-607642008546060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-854-60) 2025-01-28NoNoHistorical
76420-854-907642008549090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-854-90) 2025-01-28NoNoHistorical