FDA.reportPublic FDA data

Tadalafil

Product NDC
60290-028
11-digit product format
602900028
Labeler code
60290
Product ID
60290-028_50582108-5bae-7795-e063-6294a90aa191
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Umedica Laboratories USA Inc.
Application
ANDA211298
Marketing category
ANDA
Marketing start
2026-02-15
Substance
TADALAFIL
Active strength
5 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tadalafil
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60290-028-01Tadalafil30 in 1 BOTTLETABLET, FILM COATED302
60290-028-02Tadalafil1000 in 1 BOTTLETABLET, FILM COATED10002
60290-028-03Tadalafil30 in 1 BLISTER PACKTABLET, FILM COATED302
60290-028-04Tadalafil500 in 1 BOTTLETABLET, FILM COATED5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60290-028-01EA - Each60290-02867382c8d-0ca1-453c-ba7b-0fa409a78dfd12026-05-22
60290-028-02EA - Each60290-028456caa16-8b6b-4f0d-ae6a-ae089153cac512026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSN6caf3b55-9bf4-4355-9e25-8bf368943fdd2
757707tadalafil 2.5 MG Oral TabletPSN6caf3b55-9bf4-4355-9e25-8bf368943fdd2
402019tadalafil 20 MG Oral TabletPSN6caf3b55-9bf4-4355-9e25-8bf368943fdd2
403957tadalafil 5 MG Oral TabletPSN6caf3b55-9bf4-4355-9e25-8bf368943fdd2
484814tadalafil 10 MG Oral TabletSCD6caf3b55-9bf4-4355-9e25-8bf368943fdd2
757707tadalafil 2.5 MG Oral TabletSCD6caf3b55-9bf4-4355-9e25-8bf368943fdd2
402019tadalafil 20 MG Oral TabletSCD6caf3b55-9bf4-4355-9e25-8bf368943fdd2
403957tadalafil 5 MG Oral TabletSCD6caf3b55-9bf4-4355-9e25-8bf368943fdd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60290-028-016029000280130 TABLET, FILM COATED in 1 BOTTLE (60290-028-01) 2026-02-15NoNoCurrent
60290-028-02602900028021000 TABLET, FILM COATED in 1 BOTTLE (60290-028-02) 2026-02-15NoNoCurrent
60290-028-036029000280330 TABLET, FILM COATED in 1 BLISTER PACK (60290-028-03) 2026-02-15NoNoCurrent
60290-028-0460290002804500 TABLET, FILM COATED in 1 BOTTLE (60290-028-04) 2026-04-24NoNoCurrent