FDA.reportPublic FDA data

TADALAFIL

Product NDC
13668-568
11-digit product format
136680568
Labeler code
13668
Product ID
13668-568_8d94d098-d4f5-488c-8cc9-d21f32b727ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TADALAFIL
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA211839
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
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
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
13668-568-05TADALAFIL500 in 1 BOTTLETABLET50011
13668-568-30TADALAFIL30 in 1 BOTTLETABLET3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-568-30EA - Each13668-568bfcd8ad6-04c9-490e-979f-0415b9859c6812019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-568TADALAFIL TABLET [TORRENT PHARMACEUTICALS LIMITED]10Current NDC, Legacy NDC, 2 package rows20250514_3ea7612b-b004-43ef-accc-34c8ec5146b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSN3ea7612b-b004-43ef-accc-34c8ec5146b811
757707tadalafil 2.5 MG Oral TabletPSN3ea7612b-b004-43ef-accc-34c8ec5146b811
402019tadalafil 20 MG Oral TabletPSN3ea7612b-b004-43ef-accc-34c8ec5146b811
403957tadalafil 5 MG Oral TabletPSN3ea7612b-b004-43ef-accc-34c8ec5146b811
484814tadalafil 10 MG Oral TabletSCD3ea7612b-b004-43ef-accc-34c8ec5146b811
757707tadalafil 2.5 MG Oral TabletSCD3ea7612b-b004-43ef-accc-34c8ec5146b811
402019tadalafil 20 MG Oral TabletSCD3ea7612b-b004-43ef-accc-34c8ec5146b811
403957tadalafil 5 MG Oral TabletSCD3ea7612b-b004-43ef-accc-34c8ec5146b811
402019tadalafil 20 MG Oral TabletPSN721e4488-b2da-4c47-bc5c-8226adf1296b1
402019tadalafil 20 MG Oral TabletSCD721e4488-b2da-4c47-bc5c-8226adf1296b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-568-0513668056805500 TABLET in 1 BOTTLE (13668-568-05) 500 tablet2019-03-260000-00-00NoNoCurrent
13668-568-301366805683030 TABLET in 1 BOTTLE (13668-568-30) 30 tablet2019-03-260000-00-00NoNoCurrent
13668-568-711366805687110 TABLET in 1 BLISTER PACK (13668-568-71) 10 tablet2019-03-260000-00-00NoNoCurrent
13668-568-7413668056874100 TABLET in 1 CARTON (13668-568-74) 100 tablet2019-03-260000-00-00NoNoCurrent