FDA.reportPublic FDA data

Tadalafil

Product NDC
50090-5724
11-digit product format
500905724
Labeler code
50090
Product ID
50090-5724_3b702d9e-d57e-4754-a7bf-6d7138a1a1aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207244
Marketing category
ANDA
Marketing start
2019-10-08
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-5724IInactivated by FDA2026-07-31
excluded packagepackage50090-572450090-5724-0IInactivated by FDA2026-07-31
excluded packagepackage50090-572450090-5724-1IInactivated 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
A207244-001TADALAFILTADALAFIL2.5MGTABLET / ORALAB12019-10-07
A207244-002TADALAFILTADALAFIL5MGTABLET / ORALAB12019-10-07
A207244-003TADALAFILTADALAFIL10MGTABLET / ORALAB12019-10-07
A207244-004TADALAFILTADALAFIL20MGTABLET / ORALAB12019-10-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207244-001AB1
A207244-002AB1
A207244-003AB1
A207244-004AB1

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 22:54:322026-06A207244-001TADALAFIL2.5MGTABLET / ORALAB12019-10-07a50c72e98297…
2026-08-01 22:54:322026-06A207244-002TADALAFIL5MGTABLET / ORALAB12019-10-07a50c72e98297…
2026-08-01 22:54:322026-06A207244-003TADALAFIL10MGTABLET / ORALAB12019-10-07a50c72e98297…
2026-08-01 22:54:322026-06A207244-004TADALAFIL20MGTABLET / ORALAB12019-10-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207244-001AB11a50c72e98297…
2026-08-01 22:54:322026-06A207244-002AB11a50c72e98297…
2026-08-01 22:54:322026-06A207244-003AB11a50c72e98297…
2026-08-01 22:54:322026-06A207244-004AB11a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TadalafilTADALAFILREMEDYREPACK INC.2121cd9b-a2c0-4f19-a33d-939c6fb3826d2026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207244
application number: ANDA207244
TadalafilTADALAFILMacleods Pharmaceuticals Limited4348b7db-e5b2-4e87-8cdd-674797a188902025-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207244
application number: ANDA207244
TadalafilTADALAFILAsclemed USA, Inc.51f87c9b-038c-4793-b0d5-5359ae2310742023-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207244
application number: ANDA207244

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
50090-5724-02023-01-30C16284748780-1f386c649-b0c4-0266-e053-dadaa90a7c1aHIGHLIGHTS OF PRESCRIBING INFORMATION 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
50090-5724-12023-01-30C16284748780-1f386c649-b0c4-0266-e053-dadaa90a7c1aHIGHLIGHTS OF PRESCRIBING INFORMATION 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
50090-5724-0Tadalafil90 in 1 BOTTLETABLET, FILM COATED902
50090-5724-1Tadalafil30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5724-0EA - Each50090-5724a0bcd54c-0877-4355-9f11-b2907b35ae3e12022-08-04
50090-5724-1EA - Each50090-57247df455ef-4961-4cfa-ba86-8675e3ee93ed12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5724TADALAFIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]2Legacy NDC, 2 package rows20211001_dce8155e-b8b3-4c5b-8b8c-47c0052036c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403957tadalafil 5 MG Oral TabletPSNdce8155e-b8b3-4c5b-8b8c-47c0052036c62
403957tadalafil 5 MG Oral TabletSCDdce8155e-b8b3-4c5b-8b8c-47c0052036c62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5724-05009057240090 TABLET, FILM COATED in 1 BOTTLE (50090-5724-0) 2021-09-270000-00-00NoNoCurrent
50090-5724-15009057240130 TABLET, FILM COATED in 1 BOTTLE (50090-5724-1) 2021-09-270000-00-00NoNoCurrent