Tadalafil

Product NDC
61919-887
11-digit product format
619190887
Labeler code
61919
Product ID
61919-887_ddb7bc4e-71c8-3a98-e053-2a95a90a5641
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA209908
Marketing category
ANDA
Marketing start
2019-06-12
Marketing end
0000-00-00
Substance
TADALAFIL
Active strength
20 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
61919-887-102025-01-30C16284748780-12cef2736-9b62-d83d-e063-dadaa90ab31fTadalafil
61919-887-302025-01-30C16284748780-12cef2736-9b62-d83d-e063-dadaa90ab31fTadalafil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-887-10Tadalafil10 in 1 BOTTLETABLET, FILM COATED104
61919-887-30Tadalafil30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-887-10EA - Each61919-88795d6199d-a143-46c6-bc98-d02439eb4cb112019-11-12
61919-887-30EA - Each61919-88729de07d3-0e8a-48c6-8ffc-649df276b9c112022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-887TADALAFIL TABLET, FILM COATED [DIRECT_RX]4Legacy NDC, 2 package rows20230608_8b26f837-4265-7cb8-e053-2a95a90a1a5c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402019tadalafil 20 MG Oral TabletPSN8b26f837-4265-7cb8-e053-2a95a90a1a5c4
402019tadalafil 20 MG Oral TabletSCD8b26f837-4265-7cb8-e053-2a95a90a1a5c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-887-106191908871010 TABLET, FILM COATED in 1 BOTTLE (61919-887-10) 2019-06-120000-00-00NoNoCurrent
61919-887-306191908873010 TABLET, FILM COATED in 1 BOTTLE (61919-887-30) 2019-06-120000-00-00NoNoCurrent