FDA.reportPublic FDA data

Tadalafil

Product NDC
71335-1491
11-digit product format
713351491
Labeler code
71335
Product ID
71335-1491_d3e06344-a4f3-4e0e-89c3-6079a7acc580
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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

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
71335-1491-1Tadalafil30 in 1 BOTTLETABLET308
71335-1491-2Tadalafil10 in 1 BOTTLETABLET108
71335-1491-3Tadalafil90 in 1 BOTTLETABLET908
71335-1491-4Tadalafil5 in 1 BOTTLETABLET58
71335-1491-5Tadalafil60 in 1 BOTTLETABLET608
71335-1491-6Tadalafil20 in 1 BOTTLETABLET208
71335-1491-7Tadalafil15 in 1 BOTTLETABLET158

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1491-1EA - Each71335-1491cb6d9cbb-fdbc-4fdf-9320-f89678b6581c12025-08-11
71335-1491-2EA - Each71335-1491ce55592e-97ad-4df5-a29f-d826bb3010a412025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1491TADALAFIL TABLET [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 7 package rows20240823_85ed0cbc-df84-44df-a9eb-f9587dbc21df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402019tadalafil 20 MG Oral TabletPSN85ed0cbc-df84-44df-a9eb-f9587dbc21df8
402019tadalafil 20 MG Oral TabletSCD85ed0cbc-df84-44df-a9eb-f9587dbc21df8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1491-17133514910130 TABLET in 1 BOTTLE (71335-1491-1) 30 tablet2020-01-290000-00-00NoNoCurrent
71335-1491-27133514910210 TABLET in 1 BOTTLE (71335-1491-2) 10 tablet2020-02-250000-00-00NoNoCurrent
71335-1491-37133514910390 TABLET in 1 BOTTLE (71335-1491-3) 90 tablet2020-06-030000-00-00NoNoCurrent
71335-1491-4713351491045 TABLET in 1 BOTTLE (71335-1491-4) 5 tablet2021-08-300000-00-00NoNoCurrent
71335-1491-57133514910560 TABLET in 1 BOTTLE (71335-1491-5) 60 tablet2021-12-280000-00-00NoNoCurrent
71335-1491-67133514910620 TABLET in 1 BOTTLE (71335-1491-6) 20 tablet2021-09-230000-00-00NoNoCurrent
71335-1491-77133514910715 TABLET in 1 BOTTLE (71335-1491-7) 15 tablet2021-03-290000-00-00NoNoCurrent