FDA.reportPublic FDA data

Tadalafil

Product NDC
27241-112
11-digit product format
272410112
Labeler code
27241
Product ID
27241-112_4e9e209a-9f87-41cb-a7ac-a1fbf5412995
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA209654
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
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
27241-112-03Tadalafil30 in 1 BOTTLETABLET3012
27241-112-05Tadalafil500 in 1 BOTTLETABLET50012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-112-03EA - Each27241-11239256cb8-c0a6-479f-9690-212ce189c32212019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-112TADALAFIL TABLET [AJANTA PHARMA USA INC.]11Current NDC, Legacy NDC, 2 package rows20230523_7e4cdac1-42cc-4038-a86b-4890962ed806.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403957tadalafil 5 MG Oral TabletPSN185a3284-3a4f-44d3-9278-98581d33f95b108
403957tadalafil 5 MG Oral TabletSCD185a3284-3a4f-44d3-9278-98581d33f95b108
484814tadalafil 10 MG Oral TabletPSN7e4cdac1-42cc-4038-a86b-4890962ed80612
757707tadalafil 2.5 MG Oral TabletPSN7e4cdac1-42cc-4038-a86b-4890962ed80612
402019tadalafil 20 MG Oral TabletPSN7e4cdac1-42cc-4038-a86b-4890962ed80612
403957tadalafil 5 MG Oral TabletPSN7e4cdac1-42cc-4038-a86b-4890962ed80612
484814tadalafil 10 MG Oral TabletSCD7e4cdac1-42cc-4038-a86b-4890962ed80612
757707tadalafil 2.5 MG Oral TabletSCD7e4cdac1-42cc-4038-a86b-4890962ed80612
402019tadalafil 20 MG Oral TabletSCD7e4cdac1-42cc-4038-a86b-4890962ed80612
403957tadalafil 5 MG Oral TabletSCD7e4cdac1-42cc-4038-a86b-4890962ed80612
403957tadalafil 5 MG Oral TabletPSN415bd983-86f3-4f38-917a-9805024f31cb11
403957tadalafil 5 MG Oral TabletSCD415bd983-86f3-4f38-917a-9805024f31cb11
403957tadalafil 5 MG Oral TabletPSNc32f7cdb-d011-a2b9-e053-2a95a90af02b4
403957tadalafil 5 MG Oral TabletPSNb3ee8325-bcb2-43fd-e053-2a95a90a08c84
403957tadalafil 5 MG Oral TabletPSN2354c3e2-7b5f-4fdd-bbf2-7fa3c57686f84
403957tadalafil 5 MG Oral TabletSCDc32f7cdb-d011-a2b9-e053-2a95a90af02b4
403957tadalafil 5 MG Oral TabletSCDb3ee8325-bcb2-43fd-e053-2a95a90a08c84
403957tadalafil 5 MG Oral TabletSCD2354c3e2-7b5f-4fdd-bbf2-7fa3c57686f84
402019tadalafil 20 MG Oral TabletPSNc7654cb8-a46d-484a-a95f-59d5c4aa871f3
403957tadalafil 5 MG Oral TabletPSN599fc25a-a7af-4eeb-971f-8cf690b47e453
403957tadalafil 5 MG Oral TabletPSNc7654cb8-a46d-484a-a95f-59d5c4aa871f3
402019tadalafil 20 MG Oral TabletSCDc7654cb8-a46d-484a-a95f-59d5c4aa871f3
403957tadalafil 5 MG Oral TabletSCDc7654cb8-a46d-484a-a95f-59d5c4aa871f3
403957tadalafil 5 MG Oral TabletSCD599fc25a-a7af-4eeb-971f-8cf690b47e453
484814tadalafil 10 MG Oral TabletPSNaa345972-40b4-415e-acb5-31b808a8d8152
402019tadalafil 20 MG Oral TabletPSNaa345972-40b4-415e-acb5-31b808a8d8152
403957tadalafil 5 MG Oral TabletPSNaa345972-40b4-415e-acb5-31b808a8d8152
484814tadalafil 10 MG Oral TabletSCDaa345972-40b4-415e-acb5-31b808a8d8152
402019tadalafil 20 MG Oral TabletSCDaa345972-40b4-415e-acb5-31b808a8d8152
403957tadalafil 5 MG Oral TabletSCDaa345972-40b4-415e-acb5-31b808a8d8152
484814tadalafil 10 MG Oral TabletPSN5ea24573-2d16-40d8-a46c-7b5fa8669e691
757707tadalafil 2.5 MG Oral TabletPSN5ea24573-2d16-40d8-a46c-7b5fa8669e691
402019tadalafil 20 MG Oral TabletPSN5ea24573-2d16-40d8-a46c-7b5fa8669e691
403957tadalafil 5 MG Oral TabletPSN36350106-98bc-41fc-bede-8be5e6f54a8a1
403957tadalafil 5 MG Oral TabletPSN5ea24573-2d16-40d8-a46c-7b5fa8669e691
403957tadalafil 5 MG Oral TabletPSNc4d5d1fd-65e0-70cc-e053-2995a90a5ded1
484814tadalafil 10 MG Oral TabletSCD5ea24573-2d16-40d8-a46c-7b5fa8669e691
757707tadalafil 2.5 MG Oral TabletSCD5ea24573-2d16-40d8-a46c-7b5fa8669e691
402019tadalafil 20 MG Oral TabletSCD5ea24573-2d16-40d8-a46c-7b5fa8669e691
403957tadalafil 5 MG Oral TabletSCD5ea24573-2d16-40d8-a46c-7b5fa8669e691
403957tadalafil 5 MG Oral TabletSCDc4d5d1fd-65e0-70cc-e053-2995a90a5ded1
403957tadalafil 5 MG Oral TabletSCD36350106-98bc-41fc-bede-8be5e6f54a8a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27241-112-032724101120330 TABLET in 1 BOTTLE (27241-112-03) 30 tablet2019-03-260000-00-00NoNoCurrent
27241-112-0527241011205500 TABLET in 1 BOTTLE (27241-112-05) 500 tablet2020-06-170000-00-00NoNoCurrent