FDA.reportPublic FDA data

Tadalafil

Product NDC
76420-553
11-digit product format
764200553
Labeler code
76420
Product ID
76420-553_f7f0bf23-1272-256a-e053-6294a90a40ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA209654
Marketing category
ANDA
Marketing start
2019-03-26
Substance
TADALAFIL
Active strength
10 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
TADALAFIL10 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
76420-553-05Tadalafil500 in 1 BOTTLETABLET5001
76420-553-12Tadalafil120 in 1 BOTTLETABLET1201
76420-553-30Tadalafil30 in 1 BOTTLETABLET301
76420-553-60Tadalafil60 in 1 BOTTLETABLET601
76420-553-90Tadalafil90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-553-05EA - Each76420-5535bd76146-a7c2-4e72-b387-23b10541ecc912023-05-05
76420-553-12EA - Each76420-553e77cd8d2-def7-4c3a-820f-42fbd61eed9f12023-05-05
76420-553-30EA - Each76420-553935e5fb5-5693-48ab-920d-c7a79531ea8412023-05-05
76420-553-60EA - Each76420-553eba0adee-6a1d-4a8f-b08b-ea7409d5c5ee12023-05-05
76420-553-90EA - Each76420-553f35225b2-5f0f-49e5-b1a6-c982d49ba55c12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-553TADALAFIL TABLET [ASCLEMED USA, INC.]1Current NDC, 5 package rows20230331_5ea24573-2d16-40d8-a46c-7b5fa8669e69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSN5ea24573-2d16-40d8-a46c-7b5fa8669e691
757707tadalafil 2.5 MG Oral TabletPSN5ea24573-2d16-40d8-a46c-7b5fa8669e691
402019tadalafil 20 MG Oral TabletPSN5ea24573-2d16-40d8-a46c-7b5fa8669e691
403957tadalafil 5 MG Oral TabletPSN5ea24573-2d16-40d8-a46c-7b5fa8669e691
484814tadalafil 10 MG Oral TabletSCD5ea24573-2d16-40d8-a46c-7b5fa8669e691
757707tadalafil 2.5 MG Oral TabletSCD5ea24573-2d16-40d8-a46c-7b5fa8669e691
402019tadalafil 20 MG Oral TabletSCD5ea24573-2d16-40d8-a46c-7b5fa8669e691
403957tadalafil 5 MG Oral TabletSCD5ea24573-2d16-40d8-a46c-7b5fa8669e691

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-553-0576420055305500 TABLET in 1 BOTTLE (76420-553-05) 500 tablet2023-03-28NoNoHistorical
76420-553-1276420055312120 TABLET in 1 BOTTLE (76420-553-12) 120 tablet2023-03-28NoNoHistorical
76420-553-307642005533030 TABLET in 1 BOTTLE (76420-553-30) 30 tablet2023-03-28NoNoHistorical
76420-553-607642005536060 TABLET in 1 BOTTLE (76420-553-60) 60 tablet2023-03-28NoNoHistorical
76420-553-907642005539090 TABLET in 1 BOTTLE (76420-553-90) 90 tablet2023-03-28NoNoHistorical