FDA.reportPublic FDA data

tadalafil

Product NDC
35573-460
11-digit product format
355730460
Labeler code
35573
Product ID
35573-460_da1eee2b-ebe6-4af3-ad52-2b349a360a9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Burel Pharmaceuticals, LLC
Application
ANDA215556
Marketing category
ANDA
Marketing start
2023-04-01
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
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
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
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
35573-460-38tadalafil30 in 1 CARTONTABLET, FILM COATED304
35573-460-56tadalafil15 in 1 BLISTER PACKTABLET, FILM COATED154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35573-460-38EA - Each35573-46081bf747e-b15f-452b-8ece-319074dab7ee12023-05-05
35573-460-56EA - Each35573-460e5c9e3df-160f-497f-8ddd-a75c60593e7512023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35573-460TADALAFIL TABLET, FILM COATED [BUREL PHARMACEUTICALS, LLC]3Current NDC, 2 package rows20230401_a2e7f393-5cfc-45e5-b87d-9e8abc8e4355.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSNa2e7f393-5cfc-45e5-b87d-9e8abc8e43554
757707tadalafil 2.5 MG Oral TabletPSNa2e7f393-5cfc-45e5-b87d-9e8abc8e43554
402019tadalafil 20 MG Oral TabletPSNa2e7f393-5cfc-45e5-b87d-9e8abc8e43554
403957tadalafil 5 MG Oral TabletPSNa2e7f393-5cfc-45e5-b87d-9e8abc8e43554
484814tadalafil 10 MG Oral TabletSCDa2e7f393-5cfc-45e5-b87d-9e8abc8e43554
757707tadalafil 2.5 MG Oral TabletSCDa2e7f393-5cfc-45e5-b87d-9e8abc8e43554
402019tadalafil 20 MG Oral TabletSCDa2e7f393-5cfc-45e5-b87d-9e8abc8e43554
403957tadalafil 5 MG Oral TabletSCDa2e7f393-5cfc-45e5-b87d-9e8abc8e43554

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35573-460-383557304603830 in 1 CARTONHistorical
35573-460-563557304605615 CARTON in 1 BLISTER PACK (35573-460-56) / 30 TABLET, FILM COATED in 1 CARTON (35573-460-38) 15 carton2023-04-01NoNoHistorical