FDA.reportPublic FDA data

Tadalafil

Product NDC
61919-887
Requested package NDC
61919-887-10
11-digit product format
619190887
Labeler code
61919
Product ID
61919-887_ddb7bc4e-71c8-3a98-e053-2a95a90a5641
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA209908
Marketing category
ANDA
Marketing start
2019-06-12
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
2023-12-31
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 packagepackage61919-88761919-887-10IInactivated 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
A209908-001TADALAFILTADALAFIL2.5MGTABLET / ORALAB12019-03-26
A209908-002TADALAFILTADALAFIL5MGTABLET / ORALAB12019-03-26
A209908-003TADALAFILTADALAFIL10MGTABLET / ORALAB12019-03-26
A209908-004TADALAFILTADALAFIL20MGTABLET / 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
A209908-001AB1
A209908-002AB1
A209908-003AB1
A209908-004AB1

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 22:54:322026-06A209908-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26a50c72e98297…
2026-08-01 22:54:322026-06A209908-002TADALAFIL5MGTABLET / ORALAB12019-03-26a50c72e98297…
2026-08-01 22:54:322026-06A209908-003TADALAFIL10MGTABLET / ORALAB12019-03-26a50c72e98297…
2026-08-01 22:54:322026-06A209908-004TADALAFIL20MGTABLET / ORALAB12019-03-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209908-001AB11a50c72e98297…
2026-08-01 22:54:322026-06A209908-002AB11a50c72e98297…
2026-08-01 22:54:322026-06A209908-003AB11a50c72e98297…
2026-08-01 22:54:322026-06A209908-004AB11a50c72e98297…

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
TadalafilTADALAFILNuCare Pharmaceutical,Inc.48850075-ac57-abb7-e063-6394a90a78812026-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209908
application number: ANDA209908
TadalafilTADALAFILNuCare Pharmaceuticals, Inc.48892acb-43bb-a4d8-e063-6394a90a5d612026-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209908
application number: ANDA209908
TadalafilTADALAFILXLCare Pharmaceuticals Inc.add6afb8-d38c-47a2-8c35-d5940667bb0c2024-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209908
application number: ANDA209908
TadalafilTADALAFILA-S Medication Solutionsb9d71483-861b-465b-846b-d7bfd6cbac112023-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209908
application number: ANDA209908
TadalafilTADALAFILA-S Medication Solutionsc1c8feb4-a85a-4f39-8c44-bc9cd77226f42023-12-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209908
application number: ANDA209908
TadalafilTADALAFILCamber Pharmaceuticals, Inc.a3892605-4eb1-4d6e-a675-f7f7d4302f382019-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209908
application number: ANDA209908

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
61919-887-102025-01-30C16284748780-12cef2736-9b62-d83d-e063-dadaa90ab31fTadalafil
61919-887-302025-01-30C16284748780-12cef2736-9b62-d83d-e063-dadaa90ab31fTadalafil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-887-10Tadalafil10 in 1 BOTTLETABLET, FILM COATED104
61919-887-30Tadalafil30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-887-10EA - Each61919-88795d6199d-a143-46c6-bc98-d02439eb4cb112019-11-12
61919-887-30EA - Each61919-88729de07d3-0e8a-48c6-8ffc-649df276b9c112022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-887TADALAFIL TABLET, FILM COATED [DIRECT_RX]4Legacy NDC, 2 package rows20230608_8b26f837-4265-7cb8-e053-2a95a90a1a5c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402019tadalafil 20 MG Oral TabletPSN8b26f837-4265-7cb8-e053-2a95a90a1a5c4
402019tadalafil 20 MG Oral TabletSCD8b26f837-4265-7cb8-e053-2a95a90a1a5c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-887-106191908871010 TABLET, FILM COATED in 1 BOTTLE (61919-887-10) 2019-06-120000-00-00NoNoCurrent