FDA.reportPublic FDA data

Tadalafil

Product NDC
50090-4247
11-digit product format
500904247
Labeler code
50090
Product ID
50090-4247_eceb3f26-381b-4492-b1c4-a5ab2c47e34e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209907
Marketing category
ANDA
Marketing start
2019-02-05
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
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 productproduct50090-4247IInactivated by FDA2026-07-31
excluded packagepackage50090-424750090-4247-0IInactivated by FDA2026-07-31
excluded packagepackage50090-424750090-4247-1IInactivated 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209907-001TADALAFILTADALAFIL20MGTABLET / ORALAB22019-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209907-001AB2

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 22:54:322026-06A209907-001TADALAFIL20MGTABLET / ORALAB22019-02-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209907-001AB21a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TadalafilTADALAFILCamber Pharmaceuticals, Inc.dc0a6a03-5ef1-4507-b888-5b559653c3e92023-11-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209907
application number: ANDA209907

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
50090-4247-02023-01-30C16284748780-1f386c649-c8b7-0266-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 administration Initial U.S. Approval: 2003
50090-4247-12023-01-30C16284748780-1f386c649-c8b7-0266-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 administration Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4247-0Tadalafil30 in 1 BOTTLETABLET308
50090-4247-1Tadalafil10 in 1 BOTTLETABLET108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4247-0EA - Each50090-424749254505-2728-40d2-a8d7-a21c5c3f4ca512022-04-06
50090-4247-1EA - Each50090-4247c4b282ae-a8d0-40b7-a468-386e3194423e12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4247TADALAFIL TABLET [A-S MEDICATION SOLUTIONS]8Legacy NDC, 2 package rows20210303_8a78579b-98a6-44de-ad4e-503ab47ab56b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123194tadalafil 20 MG Pulmonary Hypertension Oral TabletPSN8a78579b-98a6-44de-ad4e-503ab47ab56b8
2123194Pulmonary Hypertension tadalafil 20 MG Oral TabletSCD8a78579b-98a6-44de-ad4e-503ab47ab56b8
2123194tadalafil 20 MG Pulmonary Hypertension Oral TabletSY8a78579b-98a6-44de-ad4e-503ab47ab56b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4247-05009042470030 TABLET in 1 BOTTLE (50090-4247-0) 30 tablet2019-04-010000-00-00NoNoCurrent
50090-4247-15009042470110 TABLET in 1 BOTTLE (50090-4247-1) 10 tablet2020-08-170000-00-00NoNoCurrent