FDA.reportPublic FDA data

Tadalafil

Product NDC
76420-126
11-digit product format
764200126
Labeler code
76420
Product ID
76420-126_d6b1a441-d2cb-e481-e053-2995a90abf78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA209167
Marketing category
ANDA
Marketing start
2019-03-27
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
Rxcui403957

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
76420-126-15Tadalafil15 in 1 BOTTLETABLET, FILM COATED152
76420-126-30Tadalafil30 in 1 BOTTLETABLET, FILM COATED302
76420-126-90Tadalafil90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-126TADALAFIL TABLET, FILM COATED [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 3 package rows20220130_aba646fe-70c2-1abb-e053-2995a90aa16d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403957tadalafil 5 MG Oral TabletPSNaba646fe-70c2-1abb-e053-2995a90aa16d2
403957tadalafil 5 MG Oral TabletSCDaba646fe-70c2-1abb-e053-2995a90aa16d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76420-126-157642001261515 TABLET, FILM COATED in 1 BOTTLE (76420-126-15) 2022-01-290000-00-00NoNoCurrent
76420-126-307642001263030 TABLET, FILM COATED in 1 BOTTLE (76420-126-30) 2020-07-300000-00-00NoNoCurrent
76420-126-907642001269090 TABLET, FILM COATED in 1 BOTTLE (76420-126-90) 2020-07-300000-00-00NoNoCurrent