FDA.reportPublic FDA data

Tadalafil

Product NDC
70771-1477
11-digit product format
707711477
Labeler code
70771
Product ID
70771-1477_89266030-a1a1-4825-b9f0-9400886b6282
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA206693
Marketing category
ANDA
Marketing start
2019-03-27
Substance
TADALAFIL
Active strength
10 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
TADALAFIL10 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
70771-1477-0Tadalafil1000 in 1 BOTTLETABLET, FILM COATED10004
70771-1477-1Tadalafil100 in 1 BOTTLETABLET, FILM COATED1004
70771-1477-3Tadalafil30 in 1 BOTTLETABLET, FILM COATED304
70771-1477-4Tadalafil2 in 1 CARTONTABLET, FILM COATED24
70771-1477-4Tadalafil15 in 1 BLISTER PACKTABLET, FILM COATED154
70771-1477-5Tadalafil500 in 1 BOTTLETABLET, FILM COATED5004
70771-1477-9Tadalafil90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1477TADALAFIL TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]4Current NDC, Legacy NDC, 7 package rows20240815_6c1c3a1f-80a4-417c-8830-5edbb9a0710f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSN6c1c3a1f-80a4-417c-8830-5edbb9a0710f4
757707tadalafil 2.5 MG Oral TabletPSN6c1c3a1f-80a4-417c-8830-5edbb9a0710f4
402019tadalafil 20 MG Oral TabletPSN6c1c3a1f-80a4-417c-8830-5edbb9a0710f4
403957tadalafil 5 MG Oral TabletPSN6c1c3a1f-80a4-417c-8830-5edbb9a0710f4
484814tadalafil 10 MG Oral TabletSCD6c1c3a1f-80a4-417c-8830-5edbb9a0710f4
757707tadalafil 2.5 MG Oral TabletSCD6c1c3a1f-80a4-417c-8830-5edbb9a0710f4
402019tadalafil 20 MG Oral TabletSCD6c1c3a1f-80a4-417c-8830-5edbb9a0710f4
403957tadalafil 5 MG Oral TabletSCD6c1c3a1f-80a4-417c-8830-5edbb9a0710f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1477-0707711477001000 TABLET, FILM COATED in 1 BOTTLE (70771-1477-0) 2019-03-270000-00-00NoNoCurrent
70771-1477-170771147701100 TABLET, FILM COATED in 1 BOTTLE (70771-1477-1) 2019-03-270000-00-00NoNoCurrent
70771-1477-37077114770330 TABLET, FILM COATED in 1 BOTTLE (70771-1477-3) 2019-03-270000-00-00NoNoCurrent
70771-1477-4707711477042 BLISTER PACK in 1 CARTON (70771-1477-4) / 15 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2019-03-270000-00-00NoNoCurrent
70771-1477-570771147705500 TABLET, FILM COATED in 1 BOTTLE (70771-1477-5) 2019-03-270000-00-00NoNoCurrent
70771-1477-97077114770990 TABLET, FILM COATED in 1 BOTTLE (70771-1477-9) 2019-03-270000-00-00NoNoCurrent