FDA.reportPublic FDA data

Tadalafil

Product NDC
24979-730
11-digit product format
249790730
Labeler code
24979
Product ID
24979-730_555edf7e-85bf-492f-8e14-c53f72aa5b38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA210420
Marketing category
ANDA
Marketing start
2024-04-07
Substance
TADALAFIL
Active strength
20 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
TADALAFIL20 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
24979-730-06Tadalafil30 in 1 BOTTLETABLET, FILM COATED303
24979-730-44Tadalafil120 in 1 BOTTLETABLET, FILM COATED1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24979-730TADALAFIL TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, LLC]2Current NDC, 2 package rows20241208_ae801b15-0462-44af-99a4-affe3eed899a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSNae801b15-0462-44af-99a4-affe3eed899a3
757707tadalafil 2.5 MG Oral TabletPSNae801b15-0462-44af-99a4-affe3eed899a3
402019tadalafil 20 MG Oral TabletPSNae801b15-0462-44af-99a4-affe3eed899a3
403957tadalafil 5 MG Oral TabletPSNae801b15-0462-44af-99a4-affe3eed899a3
484814tadalafil 10 MG Oral TabletSCDae801b15-0462-44af-99a4-affe3eed899a3
757707tadalafil 2.5 MG Oral TabletSCDae801b15-0462-44af-99a4-affe3eed899a3
402019tadalafil 20 MG Oral TabletSCDae801b15-0462-44af-99a4-affe3eed899a3
403957tadalafil 5 MG Oral TabletSCDae801b15-0462-44af-99a4-affe3eed899a3
402019tadalafil 20 MG Oral TabletPSN248a4705-1403-e94a-e063-6294a90a35441
402019tadalafil 20 MG Oral TabletSCD248a4705-1403-e94a-e063-6294a90a35441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
24979-730-062497907300630 TABLET, FILM COATED in 1 BOTTLE (24979-730-06) 2024-04-07NoNoCurrent
24979-730-4424979073044120 TABLET, FILM COATED in 1 BOTTLE (24979-730-44) 2024-04-07NoNoCurrent