FDA.reportPublic FDA data

Cialis

Product NDC
0002-4463
11-digit product format
000024463
Labeler code
0002
Product ID
0002-4463_0850d8e6-3c38-484d-990c-fd2780b46454
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
2003-11-26
Substance
TADALAFIL
Active strength
10 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cialis
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TADALAFIL10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii742SXX0ICT
Rxcui402019, 402096, 402097, 403957, 404711, 484814

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b86a08b7-54cc-440b-ad4a-3e530ccd8324Product name620230421
7a02e74a-2844-42af-84a8-96bae57351cfProduct name120230313
928d249c-35c3-4d88-a9ef-cf2f2e31b96fProduct name120220706

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-4463-30Cialis30 in 1 BOTTLETABLET, FILM COATED3051

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-4463-30EA - Each0002-4463691946a5-7d88-4408-ba0e-fc449f69a26b12012-07-24

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
TadalafilACTIVE INGREDIENT742SXX0ICTCIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TadalafilACTIVE MOIETY742SXX0ICTCIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
Cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
Croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
Hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PCIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
HypromellosesINACTIVE INGREDIENT3NXW29V3WOCIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
Magnesium stearateINACTIVE INGREDIENT70097M6I30CIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JCIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TalcINACTIVE INGREDIENT7SEV7J4R1UCIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TriacetinINACTIVE INGREDIENTXHX3C3X673CIALIS (TADALAFIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TadalafilACTIVE INGREDIENT742SXX0ICTCIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
TADALAFILACTIVE INGREDIENT742SXX0ICTCIALIS (TADALAFIL) TABLET, FILM COATED [STAT RX USA LLC]1
TadalafilACTIVE MOIETY742SXX0ICTCIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
TADALAFILACTIVE MOIETY742SXX0ICTCIALIS (TADALAFIL) TABLET, FILM COATED [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIALIS (TADALAFIL) TABLET, FILM COATED [STAT RX USA LLC]1
Cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CIALIS (TADALAFIL) TABLET, FILM COATED [STAT RX USA LLC]1
Croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCIALIS (TADALAFIL) TABLET, FILM COATED [STAT RX USA LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
Hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PCIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PCIALIS (TADALAFIL) TABLET, FILM COATED [STAT RX USA LLC]1
HypromelloseINACTIVE INGREDIENT3NXW29V3WOCIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOCIALIS (TADALAFIL) TABLET, FILM COATED [STAT RX USA LLC]1
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCIALIS (TADALAFIL) TABLET, FILM COATED [STAT RX USA LLC]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30CIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIALIS (TADALAFIL) TABLET, FILM COATED [STAT RX USA LLC]1
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JCIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCIALIS (TADALAFIL) TABLET, FILM COATED [STAT RX USA LLC]1
TalcINACTIVE INGREDIENT7SEV7J4R1UCIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCIALIS (TADALAFIL) TABLET, FILM COATED [STAT RX USA LLC]1
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIALIS (TADALAFIL) TABLET, FILM COATED [STAT RX USA LLC]1
TriacetinINACTIVE INGREDIENTXHX3C3X673CIALIS (TADALAFIL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673CIALIS (TADALAFIL) TABLET, FILM COATED [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-4463CIALIS (TADALAFIL) TABLET, FILM COATED [ELI LILLY AND COMPANY]49Current NDC, Legacy NDC, 1 package rows20241215_bcd8f8ab-81a2-4891-83db-24a0b0e25895.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402096Cialis 10 MG Oral TabletPSNbcd8f8ab-81a2-4891-83db-24a0b0e2589551
402097Cialis 20 MG Oral TabletPSNbcd8f8ab-81a2-4891-83db-24a0b0e2589551
404711Cialis 5 MG Oral TabletPSNbcd8f8ab-81a2-4891-83db-24a0b0e2589551
484814tadalafil 10 MG Oral TabletPSNbcd8f8ab-81a2-4891-83db-24a0b0e2589551
402019tadalafil 20 MG Oral TabletPSNbcd8f8ab-81a2-4891-83db-24a0b0e2589551
403957tadalafil 5 MG Oral TabletPSNbcd8f8ab-81a2-4891-83db-24a0b0e2589551
402096tadalafil 10 MG Oral Tablet [Cialis]SBDbcd8f8ab-81a2-4891-83db-24a0b0e2589551
402097tadalafil 20 MG Oral Tablet [Cialis]SBDbcd8f8ab-81a2-4891-83db-24a0b0e2589551
404711tadalafil 5 MG Oral Tablet [Cialis]SBDbcd8f8ab-81a2-4891-83db-24a0b0e2589551
484814tadalafil 10 MG Oral TabletSCDbcd8f8ab-81a2-4891-83db-24a0b0e2589551
402019tadalafil 20 MG Oral TabletSCDbcd8f8ab-81a2-4891-83db-24a0b0e2589551
403957tadalafil 5 MG Oral TabletSCDbcd8f8ab-81a2-4891-83db-24a0b0e2589551
402096Cialis 10 MG Oral TabletSYbcd8f8ab-81a2-4891-83db-24a0b0e2589551
402097Cialis 20 MG Oral TabletSYbcd8f8ab-81a2-4891-83db-24a0b0e2589551
404711Cialis 5 MG Oral TabletSYbcd8f8ab-81a2-4891-83db-24a0b0e2589551
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
402096Cialis 10 MG Oral TabletPSN0e747223-2740-4e45-9bef-ae5f7798064a2
402097Cialis 20 MG Oral TabletPSN0e747223-2740-4e45-9bef-ae5f7798064a2
404711Cialis 5 MG Oral TabletPSN0e747223-2740-4e45-9bef-ae5f7798064a2
484814tadalafil 10 MG Oral TabletPSN0e747223-2740-4e45-9bef-ae5f7798064a2
402019tadalafil 20 MG Oral TabletPSN0e747223-2740-4e45-9bef-ae5f7798064a2
403957tadalafil 5 MG Oral TabletPSN0e747223-2740-4e45-9bef-ae5f7798064a2
402096tadalafil 10 MG Oral Tablet [Cialis]SBD0e747223-2740-4e45-9bef-ae5f7798064a2
402097tadalafil 20 MG Oral Tablet [Cialis]SBD0e747223-2740-4e45-9bef-ae5f7798064a2
404711tadalafil 5 MG Oral Tablet [Cialis]SBD0e747223-2740-4e45-9bef-ae5f7798064a2
484814tadalafil 10 MG Oral TabletSCD0e747223-2740-4e45-9bef-ae5f7798064a2
402019tadalafil 20 MG Oral TabletSCD0e747223-2740-4e45-9bef-ae5f7798064a2
403957tadalafil 5 MG Oral TabletSCD0e747223-2740-4e45-9bef-ae5f7798064a2
402096Cialis 10 MG Oral TabletSY0e747223-2740-4e45-9bef-ae5f7798064a2
402097Cialis 20 MG Oral TabletSY0e747223-2740-4e45-9bef-ae5f7798064a2
404711Cialis 5 MG Oral TabletSY0e747223-2740-4e45-9bef-ae5f7798064a2
402096Cialis 10 MG Oral TabletPSN6a8621eb-7415-42a6-9432-630751d34c6b1
402096Cialis 10 MG Oral TabletPSNebddb745-81f9-4b25-8739-b2886032ed261
402097Cialis 20 MG Oral TabletPSNebddb745-81f9-4b25-8739-b2886032ed261
484814tadalafil 10 MG Oral TabletPSN6a8621eb-7415-42a6-9432-630751d34c6b1
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
402096tadalafil 10 MG Oral Tablet [Cialis]SBD6a8621eb-7415-42a6-9432-630751d34c6b1
402097tadalafil 20 MG Oral Tablet [Cialis]SBDebddb745-81f9-4b25-8739-b2886032ed261
484814tadalafil 10 MG Oral TabletSCDebddb745-81f9-4b25-8739-b2886032ed261
484814tadalafil 10 MG Oral TabletSCD6a8621eb-7415-42a6-9432-630751d34c6b1
402019tadalafil 20 MG Oral TabletSCDebddb745-81f9-4b25-8739-b2886032ed261
402096Cialis 10 MG Oral TabletSY6a8621eb-7415-42a6-9432-630751d34c6b1
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0002-4463-300000244633030 TABLET, FILM COATED in 1 BOTTLE (0002-4463-30) 2003-11-260000-00-00NoNoCurrent