Cialis

Product NDC
21695-028
11-digit product format
216950028
Labeler code
21695
Product ID
21695-028_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
10 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-028-10Cialis10 in 1 BOTTLETABLET, FILM COATED101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-028-10EA - Each21695-028720375c7-0125-4216-8167-9be86aa92c0112012-07-24

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
21695-028CIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 1 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
21695-028-102169500281010 in 1 BOTTLEHistorical