FDA.reportPublic FDA data

Tadalafil

Product NDC
82968-001
11-digit product format
829680001
Labeler code
82968
Product ID
82968-001_464c2d55-32ca-db41-e063-6294a90a9103
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED
Application
ANDA217606
Marketing category
ANDA
Marketing start
2024-08-21
Substance
TADALAFIL
Active strength
2.5 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
TADALAFIL2.5 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
82968-001-03Tadalafil15 in 1 BLISTER PACKTABLET, FILM COATED152
82968-001-03Tadalafil2 in 1 CARTONTABLET, FILM COATED22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82968-001TADALAFIL TABLET, FILM COATED [FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED]1Current NDC, 2 package rows20240822_0ea97208-5afc-4943-b35c-ea850203a794.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSN0ea97208-5afc-4943-b35c-ea850203a7942
757707tadalafil 2.5 MG Oral TabletPSN0ea97208-5afc-4943-b35c-ea850203a7942
402019tadalafil 20 MG Oral TabletPSN0ea97208-5afc-4943-b35c-ea850203a7942
403957tadalafil 5 MG Oral TabletPSN0ea97208-5afc-4943-b35c-ea850203a7942
484814tadalafil 10 MG Oral TabletSCD0ea97208-5afc-4943-b35c-ea850203a7942
757707tadalafil 2.5 MG Oral TabletSCD0ea97208-5afc-4943-b35c-ea850203a7942
402019tadalafil 20 MG Oral TabletSCD0ea97208-5afc-4943-b35c-ea850203a7942
403957tadalafil 5 MG Oral TabletSCD0ea97208-5afc-4943-b35c-ea850203a7942

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82968-001-03829680001032 BLISTER PACK in 1 CARTON (82968-001-03) / 15 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2024-08-21NoNoHistorical