FDA.reportPublic FDA data

Cialis

Product NDC
55154-1832
Requested package NDC
55154-1832-8
11-digit product format
551541832
Labeler code
55154
Product ID
55154-1832_b3f337d6-d0a6-4b23-9b8d-42f52b71e367
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health
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
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55154-183255154-1832-8DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021368-001CIALISTADALAFIL5MGTABLET / ORALAB1RLD2003-11-21
N021368-002CIALISTADALAFIL10MGTABLET / ORALAB1RLD2003-11-21
N021368-003CIALISTADALAFIL20MGTABLET / ORALAB1RLD, RS2003-11-21
N021368-004CIALISTADALAFIL2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-01-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N021368-001AB1
N021368-002AB1
N021368-003AB1

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021368-001CIALIS5MGTABLET / ORALAB1RLD2003-11-21a50c72e98297…
2026-08-01 22:54:322026-06N021368-002CIALIS10MGTABLET / ORALAB1RLD2003-11-21a50c72e98297…
2026-08-01 22:54:322026-06N021368-003CIALIS20MGTABLET / ORALAB1RLD, RS2003-11-21a50c72e98297…
2026-08-01 22:54:322026-06N021368-004CIALIS2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-01-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021368-001AB11a50c72e98297…
2026-08-01 22:54:322026-06N021368-002AB11a50c72e98297…
2026-08-01 22:54:322026-06N021368-003AB11a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CialisTADALAFILEli Lilly and Companybcd8f8ab-81a2-4891-83db-24a0b0e258952026-06-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 021368
application number: NDA021368

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TadalafilACTIVE INGREDIENT742SXX0ICTCIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]1
TadalafilACTIVE MOIETY742SXX0ICTCIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]1
Cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]1
Croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOCIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]1
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30CIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]1
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JCIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]1
TalcINACTIVE INGREDIENT7SEV7J4R1UCIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]1
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]1
TriacetinINACTIVE INGREDIENTXHX3C3X673CIALIS (TADALAFIL) TABLET, FILM COATED [CARDINAL HEALTH]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-1832-855154183208540 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-1832-8) 2003-11-260000-00-00NoNoCurrent