FDA.reportPublic FDA data

Tadalafil

Product NDC
71205-502
11-digit product format
712050502
Labeler code
71205
Product ID
71205-502_081d1edf-21a6-4852-bae3-7b285a0f6441
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA209167
Marketing category
ANDA
Marketing start
2020-04-03
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
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
71205-502-10Tadalafil10 in 1 BOTTLETABLET, FILM COATED103
71205-502-15Tadalafil15 in 1 BOTTLETABLET, FILM COATED153
71205-502-30Tadalafil30 in 1 BOTTLETABLET, FILM COATED303
71205-502-60Tadalafil60 in 1 BOTTLETABLET, FILM COATED603
71205-502-90Tadalafil90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-502-15EA - Each71205-50236ee17be-0339-4333-a4df-5bb357a5c6b812021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-502TADALAFIL TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 5 package rows20220602_b539e862-d5d4-4989-a3dd-1eba66285d53.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSNb539e862-d5d4-4989-a3dd-1eba66285d533
484814tadalafil 10 MG Oral TabletSCDb539e862-d5d4-4989-a3dd-1eba66285d533

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-502-107120505021010 TABLET, FILM COATED in 1 BOTTLE (71205-502-10) 2020-11-110000-00-00NoNoCurrent
71205-502-157120505021515 TABLET, FILM COATED in 1 BOTTLE (71205-502-15) 2021-06-100000-00-00NoNoCurrent
71205-502-307120505023030 TABLET, FILM COATED in 1 BOTTLE (71205-502-30) 2020-11-110000-00-00NoNoCurrent
71205-502-607120505026060 TABLET, FILM COATED in 1 BOTTLE (71205-502-60) 2020-11-110000-00-00NoNoCurrent
71205-502-907120505029090 TABLET, FILM COATED in 1 BOTTLE (71205-502-90) 2020-11-110000-00-00NoNoCurrent