FDA.reportPublic FDA data

Tadalafil

Product NDC
71610-581
11-digit product format
716100581
Labeler code
71610
Product ID
71610-581_21f23cde-ebd8-aa67-e063-6394a90a7150
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA209744
Marketing category
ANDA
Marketing start
2021-01-21
Substance
TADALAFIL
Active strength
10 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
ndc (product): 71610-581
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

Additional Listing Data#

Finished product
Yes
Brand name base
Tadalafil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TADALAFIL10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
742SXX0ICTInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
484814Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f2e8821e-04c9-4812-8c9e-39340775cc6eAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-581-04Tadalafil4 in 1 BOTTLETABLET, FILM COATED44
71610-581-06Tadalafil6 in 1 BOTTLE, PLASTICTABLET, FILM COATED64
71610-581-12Tadalafil12 in 1 BOTTLE, PLASTICTABLET, FILM COATED124
71610-581-39Tadalafil1440 in 1 BOTTLETABLET, FILM COATED14404
71610-581-52Tadalafil18 in 1 BOTTLETABLET, FILM COATED184

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-581-04EA - Each71610-5818e44c90b-e6fd-41db-8842-bbd4c1994cd112021-09-07
71610-581-06EA - Each71610-58123bf1e70-c5e5-4c00-8207-358cf78bcb9812024-01-04
71610-581-12EA - Each71610-5811f82e60b-61a3-40af-951b-492f7c684a4712021-09-07
71610-581-39EA - Each71610-58132ae54fe-2adb-4f47-a6cb-9b729bc8f7ba12024-05-16
71610-581-52EA - Each71610-581fc2d3af3-ea46-4ecc-9487-7dba4be4feaa12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-581TADALAFIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Current NDC, Legacy NDC, 5 package rows20240915_f2e8821e-04c9-4812-8c9e-39340775cc6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSNf2e8821e-04c9-4812-8c9e-39340775cc6e4
484814tadalafil 10 MG Oral TabletSCDf2e8821e-04c9-4812-8c9e-39340775cc6e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-581-04716100581044 TABLET, FILM COATED in 1 BOTTLE (71610-581-04) 2021-07-120000-00-00NoNoCurrent
71610-581-06716100581066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-581-06) 2023-02-01NoNoCurrent
71610-581-127161005811212 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-581-12) 2021-07-120000-00-00NoNoCurrent
71610-581-39716100581391440 TABLET, FILM COATED in 1 BOTTLE (71610-581-39) 2024-04-03NoNoCurrent
71610-581-527161005815218 TABLET, FILM COATED in 1 BOTTLE (71610-581-52) 2024-09-05NoNoCurrent