FDA.reportPublic FDA data

Tadalafil

Product NDC
50090-5641
11-digit product format
500905641
Labeler code
50090
Product ID
50090-5641_1c950675-ca7e-4d14-8226-556414c24242
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5641-02023-02-06C16284748780-1f386c649-c586-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 2003
50090-5641-12023-02-06C16284748780-1f386c649-c586-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 2003
50090-5641-02023-01-30C16284748780-1f386c649-c586-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 2003
50090-5641-12023-01-30C16284748780-1f386c649-c586-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5641-0Tadalafil30 in 1 BOTTLETABLET305
50090-5641-1Tadalafil10 in 1 BOTTLETABLET105
50090-5641-2Tadalafil90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5641-0EA - Each50090-5641e526a305-ce54-4958-88d9-f64186e6884e12022-10-06
50090-5641-1EA - Each50090-5641605e8a79-32f8-49d2-aedb-5d4d0d5ff9ba12022-10-06
50090-5641-2EA - Each50090-5641c22c01e5-f6c2-4136-8920-1f2c5cbf595f12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5641TADALAFIL TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 3 package rows20240221_b1840f16-a7ea-44bd-b091-5268990aedb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402019tadalafil 20 MG Oral TabletPSNb1840f16-a7ea-44bd-b091-5268990aedb25
402019tadalafil 20 MG Oral TabletSCDb1840f16-a7ea-44bd-b091-5268990aedb25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5641-05009056410030 TABLET in 1 BOTTLE (50090-5641-0) 30 tablet2021-09-090000-00-00NoNoCurrent
50090-5641-15009056410110 TABLET in 1 BOTTLE (50090-5641-1) 10 tablet2021-09-090000-00-00NoNoCurrent
50090-5641-25009056410290 TABLET in 1 BOTTLE (50090-5641-2) 90 tablet2024-02-01NoNoCurrent