FDA.reportPublic FDA data

Tadalafil

Product NDC
71335-1400
Requested package NDC
71335-1400-1
11-digit product format
713351400
Labeler code
71335
Product ID
71335-1400_9dbc8f0c-8137-41f5-a80c-c8ba1d9111c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209744
Marketing category
ANDA
Marketing start
2019-03-27
Marketing end
0000-00-00
Substance
TADALAFIL
Active strength
10 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage71335-140071335-1400-1IInactivated by FDA2026-08-03

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
A209744-001TADALAFILTADALAFIL2.5MGTABLET / ORALAB12019-03-26
A209744-002TADALAFILTADALAFIL5MGTABLET / ORALAB12019-03-26
A209744-003TADALAFILTADALAFIL10MGTABLET / ORALAB12019-03-26
A209744-004TADALAFILTADALAFIL20MGTABLET / ORALAB12019-03-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A209744-001AB1
A209744-002AB1
A209744-003AB1
A209744-004AB1

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 22:54:322026-06A209744-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26a50c72e98297…
2026-08-01 22:54:322026-06A209744-002TADALAFIL5MGTABLET / ORALAB12019-03-26a50c72e98297…
2026-08-01 22:54:322026-06A209744-003TADALAFIL10MGTABLET / ORALAB12019-03-26a50c72e98297…
2026-08-01 22:54:322026-06A209744-004TADALAFIL20MGTABLET / ORALAB12019-03-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209744-001AB11a50c72e98297…
2026-08-01 22:54:322026-06A209744-002AB11a50c72e98297…
2026-08-01 22:54:322026-06A209744-003AB11a50c72e98297…
2026-08-01 22:54:322026-06A209744-004AB11a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TadalafilTADALAFILAmneal Pharmaceuticals NY LLC90f38460-62ad-492e-a3da-403d5a5a5d862026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209744
application number: ANDA209744
TadalafilTADALAFILAvKAREb96ae7f1-7d4a-a211-e053-2995a90ab6e22026-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209744
application number: ANDA209744
TadalafilTADALAFILAphena Pharma Solutions - Tennessee, LLCbce03930-14c5-401f-ad17-06b7709983bc2025-02-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209744
application number: ANDA209744
TadalafilTADALAFILAphena Pharma Solutions - Tennessee, LLCf2e8821e-04c9-4812-8c9e-39340775cc6e2024-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209744
application number: ANDA209744
TadalafilTADALAFILAphena Pharma Solutions - Tennessee, LLCd1dd9d05-e9d3-49ea-aeda-047536a270372024-03-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209744
application number: ANDA209744
TadalafilTADALAFILAmneal Pharmaceuticals NY LLC2cad2167-dbd1-4df8-b407-b270487d027b2019-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209744
application number: ANDA209744

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
71335-1400-12024-01-30C16284748780-11030e365-556f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 2003
71335-1400-22024-01-30C16284748780-11030e365-556f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 2003
71335-1400-32024-01-30C16284748780-11030e365-556f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 2003
71335-1400-42024-01-30C16284748780-11030e365-556f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 2003
71335-1400-52024-01-30C16284748780-11030e365-556f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1400-1Tadalafil30 in 1 BOTTLETABLET, FILM COATED302
71335-1400-2Tadalafil10 in 1 BOTTLETABLET, FILM COATED102
71335-1400-3Tadalafil60 in 1 BOTTLETABLET, FILM COATED602
71335-1400-4Tadalafil90 in 1 BOTTLETABLET, FILM COATED902
71335-1400-5Tadalafil20 in 1 BOTTLETABLET, FILM COATED202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1400TADALAFIL TABLET, FILM COATED [BRYANT RANCH PREPACK]2Legacy NDC, 5 package rows20220205_9dbc8f0c-8137-41f5-a80c-c8ba1d9111c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSN9dbc8f0c-8137-41f5-a80c-c8ba1d9111c92
484814tadalafil 10 MG Oral TabletSCD9dbc8f0c-8137-41f5-a80c-c8ba1d9111c92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1400-17133514000130 TABLET, FILM COATED in 1 BOTTLE (71335-1400-1) 2020-02-190000-00-00NoNoCurrent