FDA.reportPublic FDA data

ADCIRCA

Product NDC
43353-070
Requested package NDC
43353-070-12
11-digit product format
433530070
Labeler code
43353
Product ID
43353-070_f3f54d01-32f6-46ed-84be-4f31cb8c556e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA022332
Marketing category
NDA
Marketing start
2009-05-22
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 packagepackage43353-07043353-070-12IInactivated 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022332-001ADCIRCATADALAFIL20MGTABLET / ORALAB2RLD, RS2009-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N022332-001AB2

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 22:54:322026-06N022332-001ADCIRCA20MGTABLET / ORALAB2RLD, RS2009-05-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N022332-001AB21a50c72e98297…

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
ADCIRCATADALAFILUnited Therapeutics Corporationff61b237-be8e-461b-8114-78c52a8ad0ae2025-12-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 022332
application number: NDA022332

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
43353-070-122023-01-30C16284748780-1f386c64a-2b93-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ADCIRCA safely and effectively. See full prescribing information for ADCIRCA. ADCIRCA (tadalafil) tablets for oral administration Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-070-12ADCIRCA12 in 1 BOTTLETABLET123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-070-12EA - Each43353-0703dea25b0-2247-4b70-884c-c9f27eb8117a12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-070ADCIRCA (TADALAFIL) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Legacy NDC, 1 package rows20191220_3ca3928a-6466-4290-a228-461fa8a91735.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849866adcirca 20 MG Oral TabletPSN3ca3928a-6466-4290-a228-461fa8a917353
2123194tadalafil 20 MG Pulmonary Hypertension Oral TabletPSN3ca3928a-6466-4290-a228-461fa8a917353
849866Pulmonary Hypertension tadalafil 20 MG Oral Tablet [Adcirca]SBD3ca3928a-6466-4290-a228-461fa8a917353
2123194Pulmonary Hypertension tadalafil 20 MG Oral TabletSCD3ca3928a-6466-4290-a228-461fa8a917353
849866Adcirca 20 MG Oral TabletSY3ca3928a-6466-4290-a228-461fa8a917353
849866Adcirca 20 MG Pulmonary Hypertension Oral TabletSY3ca3928a-6466-4290-a228-461fa8a917353
2123194tadalafil 20 MG Pulmonary Hypertension Oral TabletSY3ca3928a-6466-4290-a228-461fa8a917353

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-070-124335300701212 TABLET in 1 BOTTLE (43353-070-12) 12 tablet2017-06-220000-00-00NoNoCurrent