FDA.reportPublic FDA data

Tadalafil

Product NDC
71610-298
Requested package NDC
71610-298-08
11-digit product format
716100298
Labeler code
71610
Product ID
71610-298_6900b36a-1103-4d04-a5b6-89a1637958ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA209908
Marketing category
ANDA
Marketing start
2019-03-26
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71610-29871610-298-08IInactivated 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
A209908-001TADALAFILTADALAFIL2.5MGTABLET / ORALAB12019-03-26
A209908-002TADALAFILTADALAFIL5MGTABLET / ORALAB12019-03-26
A209908-003TADALAFILTADALAFIL10MGTABLET / ORALAB12019-03-26
A209908-004TADALAFILTADALAFIL20MGTABLET / 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
A209908-001AB1
A209908-002AB1
A209908-003AB1
A209908-004AB1

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 22:54:322026-06A209908-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26a50c72e98297…
2026-08-01 22:54:322026-06A209908-002TADALAFIL5MGTABLET / ORALAB12019-03-26a50c72e98297…
2026-08-01 22:54:322026-06A209908-003TADALAFIL10MGTABLET / ORALAB12019-03-26a50c72e98297…
2026-08-01 22:54:322026-06A209908-004TADALAFIL20MGTABLET / ORALAB12019-03-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209908-001AB11a50c72e98297…
2026-08-01 22:54:322026-06A209908-002AB11a50c72e98297…
2026-08-01 22:54:322026-06A209908-003AB11a50c72e98297…
2026-08-01 22:54:322026-06A209908-004AB11a50c72e98297…

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
TadalafilTADALAFILNuCare Pharmaceutical,Inc.48850075-ac57-abb7-e063-6394a90a78812026-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209908
application number: ANDA209908
TadalafilTADALAFILNuCare Pharmaceuticals, Inc.48892acb-43bb-a4d8-e063-6394a90a5d612026-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209908
application number: ANDA209908
TadalafilTADALAFILXLCare Pharmaceuticals Inc.add6afb8-d38c-47a2-8c35-d5940667bb0c2024-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209908
application number: ANDA209908
TadalafilTADALAFILA-S Medication Solutionsb9d71483-861b-465b-846b-d7bfd6cbac112023-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209908
application number: ANDA209908
TadalafilTADALAFILA-S Medication Solutionsc1c8feb4-a85a-4f39-8c44-bc9cd77226f42023-12-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209908
application number: ANDA209908
TadalafilTADALAFILCamber Pharmaceuticals, Inc.a3892605-4eb1-4d6e-a675-f7f7d4302f382019-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209908
application number: ANDA209908

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
71610-298-082023-01-30C16284748780-1f386c649-abbc-0266-e053-dadaa90a7c1aThese 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
71610-298-112023-01-30C16284748780-1f386c649-abbc-0266-e053-dadaa90a7c1aThese 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
71610-298-232023-01-30C16284748780-1f386c649-abbc-0266-e053-dadaa90a7c1aThese 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
71610-298-472023-01-30C16284748780-1f386c649-abbc-0266-e053-dadaa90a7c1aThese 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
71610-298-08Tadalafil8 in 1 BOTTLETABLET, FILM COATED81
71610-298-11Tadalafil48 in 1 BOTTLETABLET, FILM COATED481
71610-298-23Tadalafil16 in 1 BOTTLETABLET, FILM COATED161
71610-298-47Tadalafil24 in 1 BOTTLETABLET, FILM COATED241

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-298-08EA - Each71610-2981a1bdf0b-c7cb-4ad5-a48b-7bb635b9695912019-08-06
71610-298-11EA - Each71610-29849ebfd39-df77-406c-b0a0-d3194736e81612019-08-06
71610-298-23EA - Each71610-2988c3c0a7e-a2fd-4c0e-9d96-f48e12ccc78412019-08-06
71610-298-47EA - Each71610-2980dcf771c-a0bb-468e-9673-5f3a4e617d9f12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-298TADALAFIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 4 package rows20190704_3dd48d6b-2335-4f50-8760-fb1a8bf226c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403957tadalafil 5 MG Oral TabletPSN3dd48d6b-2335-4f50-8760-fb1a8bf226c01
403957tadalafil 5 MG Oral TabletSCD3dd48d6b-2335-4f50-8760-fb1a8bf226c01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-298-08716100298088 TABLET, FILM COATED in 1 BOTTLE (71610-298-08) 2019-07-010000-00-00NoNoCurrent