FDA.reportPublic FDA data

Tadalafil

Product NDC
71205-735
11-digit product format
712050735
Labeler code
71205
Product ID
71205-735_a72a1311-aa68-4567-ac58-97081f675d73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
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

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
71205-735-10Tadalafil10 in 1 BOTTLETABLET102
71205-735-14Tadalafil14 in 1 BOTTLETABLET142
71205-735-15Tadalafil15 in 1 BOTTLETABLET152
71205-735-20Tadalafil20 in 1 BOTTLETABLET202
71205-735-30Tadalafil30 in 1 BOTTLETABLET302
71205-735-60Tadalafil60 in 1 BOTTLETABLET602
71205-735-90Tadalafil90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-735-30EA - Each71205-73503169384-3af8-43a4-8abc-8a2931de649912023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-735TADALAFIL TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 7 package rows20230309_aa345972-40b4-415e-acb5-31b808a8d815.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSNaa345972-40b4-415e-acb5-31b808a8d8152
402019tadalafil 20 MG Oral TabletPSNaa345972-40b4-415e-acb5-31b808a8d8152
403957tadalafil 5 MG Oral TabletPSNaa345972-40b4-415e-acb5-31b808a8d8152
484814tadalafil 10 MG Oral TabletSCDaa345972-40b4-415e-acb5-31b808a8d8152
402019tadalafil 20 MG Oral TabletSCDaa345972-40b4-415e-acb5-31b808a8d8152
403957tadalafil 5 MG Oral TabletSCDaa345972-40b4-415e-acb5-31b808a8d8152

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-735-107120507351010 TABLET in 1 BOTTLE (71205-735-10) 10 tablet2023-03-03NoNoCurrent
71205-735-147120507351414 TABLET in 1 BOTTLE (71205-735-14) 14 tablet2023-03-03NoNoCurrent
71205-735-157120507351515 TABLET in 1 BOTTLE (71205-735-15) 15 tablet2023-03-03NoNoCurrent
71205-735-207120507352020 TABLET in 1 BOTTLE (71205-735-20) 20 tablet2023-03-03NoNoCurrent
71205-735-307120507353030 TABLET in 1 BOTTLE (71205-735-30) 30 tablet2022-12-230000-00-00NoNoCurrent
71205-735-607120507356060 TABLET in 1 BOTTLE (71205-735-60) 60 tablet2022-12-230000-00-00NoNoCurrent
71205-735-907120507359090 TABLET in 1 BOTTLE (71205-735-90) 90 tablet2022-12-230000-00-00NoNoCurrent