FDA.reportPublic FDA data

Tadalafil

Product NDC
47335-010
11-digit product format
473350010
Labeler code
47335
Product ID
47335-010_5f176ab2-0dba-4418-8aee-27a110ed6396
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA208934
Marketing category
ANDA
Marketing start
2019-03-26
Substance
TADALAFIL
Active strength
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
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
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
47335-010-64Tadalafil15 in 1 BLISTER PACKTABLET, FILM COATED156
47335-010-64Tadalafil2 in 1 CARTONTABLET, FILM COATED26
47335-010-83Tadalafil30 in 1 BOTTLETABLET, FILM COATED306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-010-83EA - Each47335-0104c281309-de96-4173-b22a-7cc2efdbeb8c12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-010TADALAFIL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]6Current NDC, Legacy NDC, 3 package rows20231013_168a135b-1454-4def-9b03-c9a470bfcb5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403957tadalafil 5 MG Oral TabletPSN6fd94914-0c9d-4268-8ed8-3c2690707a5d101
403957tadalafil 5 MG Oral TabletSCD6fd94914-0c9d-4268-8ed8-3c2690707a5d101
484814tadalafil 10 MG Oral TabletPSN168a135b-1454-4def-9b03-c9a470bfcb5f6
757707tadalafil 2.5 MG Oral TabletPSN168a135b-1454-4def-9b03-c9a470bfcb5f6
402019tadalafil 20 MG Oral TabletPSN168a135b-1454-4def-9b03-c9a470bfcb5f6
403957tadalafil 5 MG Oral TabletPSN168a135b-1454-4def-9b03-c9a470bfcb5f6
484814tadalafil 10 MG Oral TabletSCD168a135b-1454-4def-9b03-c9a470bfcb5f6
757707tadalafil 2.5 MG Oral TabletSCD168a135b-1454-4def-9b03-c9a470bfcb5f6
402019tadalafil 20 MG Oral TabletSCD168a135b-1454-4def-9b03-c9a470bfcb5f6
403957tadalafil 5 MG Oral TabletSCD168a135b-1454-4def-9b03-c9a470bfcb5f6
402019tadalafil 20 MG Oral TabletPSN059b4496-bbfd-4058-ab03-91c5c223b9451
403957tadalafil 5 MG Oral TabletPSN059b4496-bbfd-4058-ab03-91c5c223b9451
402019tadalafil 20 MG Oral TabletSCD059b4496-bbfd-4058-ab03-91c5c223b9451
403957tadalafil 5 MG Oral TabletSCD059b4496-bbfd-4058-ab03-91c5c223b9451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-010-64473350010642 BLISTER PACK in 1 CARTON (47335-010-64) / 15 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2019-03-260000-00-00NoNoCurrent
47335-010-72473350010721 BLISTER PACK in 1 CARTON (47335-010-72) > 15 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2019-03-260000-00-00NoNoCurrent
47335-010-834733500108330 TABLET, FILM COATED in 1 BOTTLE (47335-010-83) 2019-03-260000-00-00NoNoCurrent