FDA.reportPublic FDA data

Cialis

Product NDC
21695-029
11-digit product format
216950029
Labeler code
21695
Product ID
21695-029_a2e793ab-7e78-463d-9bad-312af00f2e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
NDA021368
Marketing category
NDA
Marketing start
2003-11-26
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
E
Listing certified through
2017-12-31
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
21695-029-102019-09-24C16284748780-1934fe258-494d-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use CIALIS safely and effectively. See full prescribing information for CIALIS. CIALIS (tadalafil) tablet, film coated for oral use Initial U.S. Approval: 2003
21695-029-162019-09-24C16284748780-1934fe258-494d-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use CIALIS safely and effectively. See full prescribing information for CIALIS. CIALIS (tadalafil) tablet, film coated for oral use Initial U.S. Approval: 2003
21695-029-302019-09-24C16284748780-1934fe258-494d-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use CIALIS safely and effectively. See full prescribing information for CIALIS. CIALIS (tadalafil) tablet, film coated for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-029-10Cialis10 in 1 BOTTLETABLET, FILM COATED101
21695-029-16Cialis16 in 1 BOTTLETABLET, FILM COATED161
21695-029-30Cialis30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-029-10EA - Each21695-029c2993399-e981-47a6-91de-ae3009bbb25512012-07-24
21695-029-16EA - Each21695-029b08d8945-03b0-413a-8a9e-71f3ef5d868612012-07-24
21695-029-30EA - Each21695-029f508884c-3987-4ec0-acb7-d3bdcdada0db12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TadalafilACTIVE INGREDIENT742SXX0ICTCIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
TadalafilACTIVE MOIETY742SXX0ICTCIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
Cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
Croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
Hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PCIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
HypromelloseINACTIVE INGREDIENT3NXW29V3WOCIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30CIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JCIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
TalcINACTIVE INGREDIENT7SEV7J4R1UCIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
TriacetinINACTIVE INGREDIENTXHX3C3X673CIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-029CIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 3 package rows20100329_ebddb745-81f9-4b25-8739-b2886032ed26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402096Cialis 10 MG Oral TabletPSNebddb745-81f9-4b25-8739-b2886032ed261
402097Cialis 20 MG Oral TabletPSNebddb745-81f9-4b25-8739-b2886032ed261
484814tadalafil 10 MG Oral TabletPSNebddb745-81f9-4b25-8739-b2886032ed261
402019tadalafil 20 MG Oral TabletPSNebddb745-81f9-4b25-8739-b2886032ed261
402096tadalafil 10 MG Oral Tablet [Cialis]SBDebddb745-81f9-4b25-8739-b2886032ed261
402097tadalafil 20 MG Oral Tablet [Cialis]SBDebddb745-81f9-4b25-8739-b2886032ed261
484814tadalafil 10 MG Oral TabletSCDebddb745-81f9-4b25-8739-b2886032ed261
402019tadalafil 20 MG Oral TabletSCDebddb745-81f9-4b25-8739-b2886032ed261
402096Cialis 10 MG Oral TabletSYebddb745-81f9-4b25-8739-b2886032ed261
402097Cialis 20 MG Oral TabletSYebddb745-81f9-4b25-8739-b2886032ed261

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-029-102169500291010 in 1 BOTTLEHistorical
21695-029-162169500291616 in 1 BOTTLEHistorical
21695-029-302169500293030 in 1 BOTTLEHistorical