FDA.reportPublic FDA data

Tadalafil

Product NDC
68382-896
11-digit product format
683820896
Labeler code
68382
Product ID
68382-896_5a958db7-5c0e-4cf0-9227-230886cf9bf8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA206693
Marketing category
ANDA
Marketing start
2019-03-27
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
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
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
68382-896-01Tadalafil100 in 1 BOTTLETABLET, FILM COATED1004
68382-896-05Tadalafil500 in 1 BOTTLETABLET, FILM COATED5004
68382-896-06Tadalafil30 in 1 BOTTLETABLET, FILM COATED304
68382-896-10Tadalafil1000 in 1 BOTTLETABLET, FILM COATED10004
68382-896-16Tadalafil90 in 1 BOTTLETABLET, FILM COATED904
68382-896-99Tadalafil2 in 1 CARTONTABLET, FILM COATED24
68382-896-99Tadalafil15 in 1 BLISTER PACKTABLET, FILM COATED154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-896TADALAFIL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]4Current NDC, Legacy NDC, 7 package rows20231110_cfe43ab8-8721-4db8-8810-f0072cf8f4d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSNcfe43ab8-8721-4db8-8810-f0072cf8f4d34
757707tadalafil 2.5 MG Oral TabletPSNcfe43ab8-8721-4db8-8810-f0072cf8f4d34
402019tadalafil 20 MG Oral TabletPSNcfe43ab8-8721-4db8-8810-f0072cf8f4d34
403957tadalafil 5 MG Oral TabletPSNcfe43ab8-8721-4db8-8810-f0072cf8f4d34
484814tadalafil 10 MG Oral TabletSCDcfe43ab8-8721-4db8-8810-f0072cf8f4d34
757707tadalafil 2.5 MG Oral TabletSCDcfe43ab8-8721-4db8-8810-f0072cf8f4d34
402019tadalafil 20 MG Oral TabletSCDcfe43ab8-8721-4db8-8810-f0072cf8f4d34
403957tadalafil 5 MG Oral TabletSCDcfe43ab8-8721-4db8-8810-f0072cf8f4d34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-896-0168382089601100 TABLET, FILM COATED in 1 BOTTLE (68382-896-01) 2019-03-270000-00-00NoNoCurrent
68382-896-0568382089605500 TABLET, FILM COATED in 1 BOTTLE (68382-896-05) 2019-03-270000-00-00NoNoCurrent
68382-896-066838208960630 TABLET, FILM COATED in 1 BOTTLE (68382-896-06) 2019-03-270000-00-00NoNoCurrent
68382-896-10683820896101000 TABLET, FILM COATED in 1 BOTTLE (68382-896-10) 2019-03-270000-00-00NoNoCurrent
68382-896-166838208961690 TABLET, FILM COATED in 1 BOTTLE (68382-896-16) 2019-03-270000-00-00NoNoCurrent
68382-896-99683820896992 BLISTER PACK in 1 CARTON (68382-896-99) / 15 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2019-03-270000-00-00NoNoCurrent