FDA.reportPublic FDA data

Cialis

Product NDC
50436-4462
11-digit product format
504364462
Labeler code
50436
Product ID
50436-4462_6e973607-b0ac-459a-81e1-02d5c4970015
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
NDA021368
Marketing category
NDA
Marketing start
2003-11-26
Marketing end
0000-00-00
Substance
TADALAFIL
Active strength
5 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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50436-4462IInactivated by FDA2026-07-31
excluded packagepackage50436-446250436-4462-1IInactivated by FDA2026-07-31
excluded packagepackage50436-446250436-4462-2IInactivated by FDA2026-07-31

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N021368-004CIALISTADALAFIL2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-01-07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 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
50436-4462-12021-01-29C16284748780-1ba0f9c33-4323-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CIALIS safely and effectively. See full prescribing information for CIALIS. CIALIS (tadalafil) tablets, for oral use Initial U.S. Approval: 2003
50436-4462-22021-01-29C16284748780-1ba0f9c33-4323-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CIALIS safely and effectively. See full prescribing information for CIALIS. CIALIS (tadalafil) tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-4462-1Cialis1 in 1 POUCHTABLET, FILM COATED16
50436-4462-1Cialis200 in 1 CASETABLET, FILM COATED2006
50436-4462-2Cialis30 in 1 BOTTLETABLET, FILM COATED306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-4462CIALIS (TADALAFIL) TABLET, FILM COATED [UNIT DOSE SERVICES]6Legacy NDC, 3 package rows20190222_ee053358-9746-4475-9d3d-ca83ea84c125.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 formatDescriptionStatus
50436-4462-1504364462011 in 1 POUCHHistorical
50436-4462-25043644620230 in 1 BOTTLEHistorical