FDA.reportPublic FDA data

Tadalafil

Product NDC
71335-1670
11-digit product format
713351670
Labeler code
71335
Product ID
71335-1670_e63fb184-d584-4d53-966d-86b8c010c972
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
10 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
TADALAFIL10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii742SXX0ICT
Rxcui484814

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
71335-1670-1Tadalafil30 in 1 BOTTLETABLET3011
71335-1670-2Tadalafil10 in 1 BOTTLETABLET1011
71335-1670-3Tadalafil60 in 1 BOTTLETABLET6011
71335-1670-4Tadalafil90 in 1 BOTTLETABLET9011
71335-1670-5Tadalafil20 in 1 BOTTLETABLET2011
71335-1670-6Tadalafil6 in 1 BOTTLETABLET611

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1670-1EA - Each71335-167088892ef5-d7fe-4138-b297-26b54d84748712023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1670TADALAFIL TABLET [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 6 package rows20240809_c835a34a-9bae-4d88-b951-1b78ab92f388.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSNc835a34a-9bae-4d88-b951-1b78ab92f38811
484814tadalafil 10 MG Oral TabletSCDc835a34a-9bae-4d88-b951-1b78ab92f38811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1670-17133516700130 TABLET in 1 BOTTLE (71335-1670-1) 30 tablet2020-07-270000-00-00NoNoCurrent
71335-1670-27133516700210 TABLET in 1 BOTTLE (71335-1670-2) 10 tablet2021-01-290000-00-00NoNoCurrent
71335-1670-37133516700360 TABLET in 1 BOTTLE (71335-1670-3) 60 tablet2022-02-140000-00-00NoNoCurrent
71335-1670-47133516700490 TABLET in 1 BOTTLE (71335-1670-4) 90 tablet2020-10-200000-00-00NoNoCurrent
71335-1670-57133516700520 TABLET in 1 BOTTLE (71335-1670-5) 20 tablet2022-02-140000-00-00NoNoCurrent
71335-1670-6713351670066 TABLET in 1 BOTTLE (71335-1670-6) 6 tablet2022-02-14NoNoHistorical