FDA.reportPublic FDA data

Tadalafil

Product NDC
71610-353
Requested package NDC
71610-353-04
11-digit product format
716100353
Labeler code
71610
Product ID
71610-353_b5ab073b-8449-4044-be5e-fc4aee8835c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090141
Marketing category
ANDA
Marketing start
2018-10-09
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 packagepackage71610-35371610-353-04IInactivated 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
A090141-001TADALAFILTADALAFIL2.5MGTABLET / ORALAB12018-05-22
A090141-002TADALAFILTADALAFIL5MGTABLET / ORALAB12018-05-22
A090141-003TADALAFILTADALAFIL10MGTABLET / ORALAB12018-05-22
A090141-004TADALAFILTADALAFIL20MGTABLET / ORALAB12018-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090141-001AB1
A090141-002AB1
A090141-003AB1
A090141-004AB1

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 22:54:322026-06A090141-001TADALAFIL2.5MGTABLET / ORALAB12018-05-22a50c72e98297…
2026-08-01 22:54:322026-06A090141-002TADALAFIL5MGTABLET / ORALAB12018-05-22a50c72e98297…
2026-08-01 22:54:322026-06A090141-003TADALAFIL10MGTABLET / ORALAB12018-05-22a50c72e98297…
2026-08-01 22:54:322026-06A090141-004TADALAFIL20MGTABLET / ORALAB12018-05-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090141-001AB11a50c72e98297…
2026-08-01 22:54:322026-06A090141-002AB11a50c72e98297…
2026-08-01 22:54:322026-06A090141-003AB11a50c72e98297…
2026-08-01 22:54:322026-06A090141-004AB11a50c72e98297…

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b86a08b7-54cc-440b-ad4a-3e530ccd8324Product name620230421
7a02e74a-2844-42af-84a8-96bae57351cfProduct name120230313
928d249c-35c3-4d88-a9ef-cf2f2e31b96fProduct name120220706
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71610-353-042023-01-30C16284748780-1f386c64a-13f3-0266-e053-dadaa90a7c1aTadalafil Tablets USP Rx Only These 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
71610-353-062023-01-30C16284748780-1f386c64a-13f3-0266-e053-dadaa90a7c1aTadalafil Tablets USP Rx Only These 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
71610-353-122023-01-30C16284748780-1f386c64a-13f3-0266-e053-dadaa90a7c1aTadalafil Tablets USP Rx Only These 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
71610-353-04Tadalafil4 in 1 BOTTLETABLET, FILM COATED42
71610-353-06Tadalafil6 in 1 BOTTLETABLET, FILM COATED62
71610-353-12Tadalafil12 in 1 BOTTLETABLET, FILM COATED122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-353-04EA - Each71610-3538211f84f-f076-40b0-b049-d8a9cfd9cb9712019-12-10
71610-353-06EA - Each71610-353db284e51-7eac-4908-9ccb-1a2f56bbef1812019-12-10
71610-353-12EA - Each71610-3531ab5a4fc-4af7-496a-a021-aefa7869e5d712019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-353TADALAFIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 3 package rows20191126_93b97b99-1bca-4390-abad-d52712818065.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402019tadalafil 20 MG Oral TabletPSN93b97b99-1bca-4390-abad-d527128180652
403957tadalafil 5 MG Oral TabletPSN93b97b99-1bca-4390-abad-d527128180652
402019tadalafil 20 MG Oral TabletSCD93b97b99-1bca-4390-abad-d527128180652
403957tadalafil 5 MG Oral TabletSCD93b97b99-1bca-4390-abad-d527128180652

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-353-04716100353044 TABLET, FILM COATED in 1 BOTTLE (71610-353-04) 2019-10-180000-00-00NoNoCurrent