FDA.reportPublic FDA data

Tadalafil

Product NDC
27241-114
11-digit product format
272410114
Labeler code
27241
Product ID
27241-114_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
20 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
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
27241-114-03Tadalafil30 in 1 BOTTLETABLET3012
27241-114-05Tadalafil500 in 1 BOTTLETABLET50012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-114-03EA - Each27241-11463eaa979-745f-4baa-9bbe-f92cdc8c86d112019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-114TADALAFIL 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
402019tadalafil 20 MG Oral TabletPSN7e236f83-14bf-4862-91fb-74d766aef6a915
402019tadalafil 20 MG Oral TabletSCD7e236f83-14bf-4862-91fb-74d766aef6a915
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
402019tadalafil 20 MG Oral TabletPSN85ed0cbc-df84-44df-a9eb-f9587dbc21df8
402019tadalafil 20 MG Oral TabletSCD85ed0cbc-df84-44df-a9eb-f9587dbc21df8
402019tadalafil 20 MG Oral TabletPSNb1840f16-a7ea-44bd-b091-5268990aedb25
402019tadalafil 20 MG Oral TabletSCDb1840f16-a7ea-44bd-b091-5268990aedb25
402019tadalafil 20 MG Oral TabletPSNc3409762-3b2b-1cfc-e053-2995a90ab91b4
402019tadalafil 20 MG Oral TabletSCDc3409762-3b2b-1cfc-e053-2995a90ab91b4
402019tadalafil 20 MG Oral TabletPSNc7654cb8-a46d-484a-a95f-59d5c4aa871f3
402019tadalafil 20 MG Oral TabletPSN761dc0f8-2f65-4615-ab49-a4bcffd40ce93
403957tadalafil 5 MG Oral TabletPSNc7654cb8-a46d-484a-a95f-59d5c4aa871f3
402019tadalafil 20 MG Oral TabletSCD761dc0f8-2f65-4615-ab49-a4bcffd40ce93
402019tadalafil 20 MG Oral TabletSCDc7654cb8-a46d-484a-a95f-59d5c4aa871f3
403957tadalafil 5 MG Oral TabletSCDc7654cb8-a46d-484a-a95f-59d5c4aa871f3
484814tadalafil 10 MG Oral TabletPSNaa345972-40b4-415e-acb5-31b808a8d8152
402019tadalafil 20 MG Oral TabletPSNad288e9d-020a-43a0-9c07-320c5c3bbc1e2
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
402019tadalafil 20 MG Oral TabletSCDad288e9d-020a-43a0-9c07-320c5c3bbc1e2
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
402019tadalafil 20 MG Oral TabletPSNd6e8c52f-4dc3-5d54-e053-2995a90a93581
402019tadalafil 20 MG Oral TabletPSN130358f4-1b5b-5b60-e063-6394a90aa1d51
402019tadalafil 20 MG Oral TabletPSN6213fd38-9580-4253-91d2-14c28a711c201
403957tadalafil 5 MG Oral TabletPSN5ea24573-2d16-40d8-a46c-7b5fa8669e691
484814tadalafil 10 MG Oral TabletSCD5ea24573-2d16-40d8-a46c-7b5fa8669e691
757707tadalafil 2.5 MG Oral TabletSCD5ea24573-2d16-40d8-a46c-7b5fa8669e691
402019tadalafil 20 MG Oral TabletSCDd6e8c52f-4dc3-5d54-e053-2995a90a93581
402019tadalafil 20 MG Oral TabletSCD6213fd38-9580-4253-91d2-14c28a711c201
402019tadalafil 20 MG Oral TabletSCD5ea24573-2d16-40d8-a46c-7b5fa8669e691
402019tadalafil 20 MG Oral TabletSCD130358f4-1b5b-5b60-e063-6394a90aa1d51
403957tadalafil 5 MG Oral TabletSCD5ea24573-2d16-40d8-a46c-7b5fa8669e691

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27241-114-032724101140330 TABLET in 1 BOTTLE (27241-114-03) 30 tablet2019-03-260000-00-00NoNoCurrent
27241-114-0527241011405500 TABLET in 1 BOTTLE (27241-114-05) 500 tablet2020-06-170000-00-00NoNoCurrent