FDA.reportPublic FDA data

Tadalafil

Product NDC
70518-3001
Requested package NDC
70518-3001-0
11-digit product format
705183001
Labeler code
70518
Product ID
70518-3001_ba9a5b9e-7a95-5de2-e053-2995a90a43b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA209744
Marketing category
ANDA
Marketing start
2021-01-28
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
2022-12-31
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 packagepackage70518-300170518-3001-0DDiscontinued by firm2026-07-31

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3001-02023-03-14C16284748780-1f386c64a-1a80-0266-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
70518-3001-12023-03-14C16284748780-1f386c64a-1a80-0266-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
70518-3001-02023-01-30C16284748780-1f386c64a-1a80-0266-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
70518-3001-12023-01-30C16284748780-1f386c64a-1a80-0266-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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3001-07051830010030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3001-0) 2021-01-280000-00-00NoNoCurrent