FDA.reportPublic FDA data

Cialis

Product NDC
0002-4465
11-digit product format
000024465
Labeler code
0002
Product ID
0002-4465_05dbd8b6-1b9d-436a-a67c-8a16713f753f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Eli Lilly and Company
Application
NDA021368
Marketing category
NDA
Marketing start
2008-01-07
Marketing end
0000-00-00
Substance
TADALAFIL
Active strength
3 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-4465-34EA - Each0002-4465ab35df6c-21c6-4314-ba76-dbcfd94ffbe512012-07-24
0002-4465-79EA - Each0002-4465f3a80565-bc52-4ea4-baa1-77514c347dac12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TadalafilACTIVE INGREDIENT742SXX0ICTCIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]33
TadalafilACTIVE MOIETY742SXX0ICTCIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]33
Cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]33
Croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]33
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]33
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]33
Hydroxypropyl cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PCIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]33
HypromellosesINACTIVE INGREDIENT3NXW29V3WOCIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]33
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]33
Magnesium stearateINACTIVE INGREDIENT70097M6I30CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]33
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JCIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]33
TalcINACTIVE INGREDIENT7SEV7J4R1UCIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]33
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]33
TriacetinINACTIVE INGREDIENTXHX3C3X673CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-4465CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]49Legacy NDC20241215_bcd8f8ab-81a2-4891-83db-24a0b0e25895.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402096Cialis 10 MG Oral TabletPSNee053358-9746-4475-9d3d-ca83ea84c1256
762660Cialis 2.5 MG Oral TabletPSNee053358-9746-4475-9d3d-ca83ea84c1256
402097Cialis 20 MG Oral TabletPSNee053358-9746-4475-9d3d-ca83ea84c1256
404711Cialis 5 MG Oral TabletPSNee053358-9746-4475-9d3d-ca83ea84c1256
484814tadalafil 10 MG Oral TabletPSNee053358-9746-4475-9d3d-ca83ea84c1256
757707tadalafil 2.5 MG Oral TabletPSNee053358-9746-4475-9d3d-ca83ea84c1256
402019tadalafil 20 MG Oral TabletPSNee053358-9746-4475-9d3d-ca83ea84c1256
403957tadalafil 5 MG Oral TabletPSNee053358-9746-4475-9d3d-ca83ea84c1256
402096tadalafil 10 MG Oral Tablet [Cialis]SBDee053358-9746-4475-9d3d-ca83ea84c1256
762660tadalafil 2.5 MG Oral Tablet [Cialis]SBDee053358-9746-4475-9d3d-ca83ea84c1256
402097tadalafil 20 MG Oral Tablet [Cialis]SBDee053358-9746-4475-9d3d-ca83ea84c1256
404711tadalafil 5 MG Oral Tablet [Cialis]SBDee053358-9746-4475-9d3d-ca83ea84c1256
484814tadalafil 10 MG Oral TabletSCDee053358-9746-4475-9d3d-ca83ea84c1256
757707tadalafil 2.5 MG Oral TabletSCDee053358-9746-4475-9d3d-ca83ea84c1256
402019tadalafil 20 MG Oral TabletSCDee053358-9746-4475-9d3d-ca83ea84c1256
403957tadalafil 5 MG Oral TabletSCDee053358-9746-4475-9d3d-ca83ea84c1256
402096Cialis 10 MG Oral TabletSYee053358-9746-4475-9d3d-ca83ea84c1256
762660Cialis 2.5 MG Oral TabletSYee053358-9746-4475-9d3d-ca83ea84c1256
402097Cialis 20 MG Oral TabletSYee053358-9746-4475-9d3d-ca83ea84c1256
404711Cialis 5 MG Oral TabletSYee053358-9746-4475-9d3d-ca83ea84c1256

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0002-4465-34000024465342 BLISTER PACK in 1 CARTON (0002-4465-34) > 15 TABLET, FILM COATED in 1 BLISTER PACK (0002-4465-79) 2 blister pack2008-01-070000-00-00NoNoCurrent