FDA.reportPublic FDA data

Cialis

Product NDC
43353-044
11-digit product format
433530044
Labeler code
43353
Product ID
43353-044_6962a85a-e95c-481f-bfd0-eba3742d4101
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43353-044IInactivated by FDA2026-07-31
excluded packagepackage43353-04443353-044-04IInactivated by FDA2026-07-31
excluded packagepackage43353-04443353-044-08IInactivated by FDA2026-07-31
excluded packagepackage43353-04443353-044-11IInactivated by FDA2026-07-31
excluded packagepackage43353-04443353-044-18IInactivated by FDA2026-07-31
excluded packagepackage43353-04443353-044-47IInactivated 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N021368-004CIALISTADALAFIL2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-01-07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
43353-044-042023-01-30C16284748780-1f386c649-c577-0266-e053-dadaa90a7c1aThese 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
43353-044-082023-01-30C16284748780-1f386c649-c577-0266-e053-dadaa90a7c1aThese 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
43353-044-112023-01-30C16284748780-1f386c649-c577-0266-e053-dadaa90a7c1aThese 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
43353-044-182023-01-30C16284748780-1f386c649-c577-0266-e053-dadaa90a7c1aThese 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
43353-044-472023-01-30C16284748780-1f386c649-c577-0266-e053-dadaa90a7c1aThese 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
43353-044-04Cialis4 in 1 BOTTLETABLET, FILM COATED44
43353-044-08Cialis8 in 1 BOTTLETABLET, FILM COATED84
43353-044-11Cialis48 in 1 BOTTLETABLET, FILM COATED484
43353-044-18Cialis16 in 1 BOTTLETABLET, FILM COATED164
43353-044-47Cialis24 in 1 BOTTLETABLET, FILM COATED244

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-044-04EA - Each43353-044c9c8d58d-54e0-4eb4-80f1-4a0548647a6a12016-07-19
43353-044-08EA - Each43353-0446d7f6548-438d-42dd-a05e-82ef8785646012016-07-19
43353-044-11EA - Each43353-044c7c57d32-dc49-4849-8602-e6ce5990427d12017-11-06
43353-044-18EA - Each43353-0444a8b96d9-2a03-46a8-ae5c-8b80d4e8c1db12016-07-19
43353-044-47EA - Each43353-044af08e404-24c7-4332-b496-110f975b925a12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-044CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Legacy NDC, 5 package rows20191219_6a6aa912-9a5d-4614-a2ce-53afb212aa12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
404711Cialis 5 MG Oral TabletPSN6a6aa912-9a5d-4614-a2ce-53afb212aa124
403957tadalafil 5 MG Oral TabletPSN6a6aa912-9a5d-4614-a2ce-53afb212aa124
404711tadalafil 5 MG Oral Tablet [Cialis]SBD6a6aa912-9a5d-4614-a2ce-53afb212aa124
403957tadalafil 5 MG Oral TabletSCD6a6aa912-9a5d-4614-a2ce-53afb212aa124
404711Cialis 5 MG Oral TabletSY6a6aa912-9a5d-4614-a2ce-53afb212aa124

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-044-04433530044044 TABLET, FILM COATED in 1 BOTTLE (43353-044-04) 2015-05-200000-00-00NoNoCurrent
43353-044-08433530044088 TABLET, FILM COATED in 1 BOTTLE (43353-044-08) 2015-05-200000-00-00NoNoCurrent
43353-044-114335300441148 TABLET, FILM COATED in 1 BOTTLE (43353-044-11) 2017-01-030000-00-00NoNoCurrent
43353-044-184335300441816 TABLET, FILM COATED in 1 BOTTLE (43353-044-18) 2015-05-190000-00-00NoNoCurrent
43353-044-474335300444724 TABLET, FILM COATED in 1 BOTTLE (43353-044-47) 2017-01-030000-00-00NoNoCurrent