FDA.reportPublic FDA data

tadalafil

Product NDC
68071-3777
11-digit product format
680713777
Labeler code
68071
Product ID
68071-3777_3a75ea22-7594-c281-e063-6294a90acac4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA209250
Marketing category
ANDA
Marketing start
2019-03-26
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
Rxcui402019

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
68071-3777-4tadalafil24 in 1 BOTTLE, PLASTICTABLET, FILM COATED243
68071-3777-5tadalafil15 in 1 BOTTLE, PLASTICTABLET, FILM COATED153
68071-3777-6tadalafil60 in 1 BOTTLE, PLASTICTABLET, FILM COATED603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3777TADALAFIL TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 3 package rows20250424_2c277890-3c5d-5fd5-e063-6394a90af15b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402019tadalafil 20 MG Oral TabletPSN2c277890-3c5d-5fd5-e063-6394a90af15b3
402019tadalafil 20 MG Oral TabletSCD2c277890-3c5d-5fd5-e063-6394a90af15b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3777-46807137770424 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68071-3777-4) 2025-01-20NoNoHistorical
68071-3777-56807137770515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68071-3777-5) 2025-01-20NoNoHistorical
68071-3777-66807137770660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68071-3777-6) 2025-04-21NoNoHistorical