FDA.reportPublic FDA data

Tadalafil

Product NDC
68071-5092
11-digit product format
680715092
Labeler code
68071
Product ID
68071-5092_bbf25e24-4c0e-d303-e053-2a95a90a634d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA209908
Marketing category
ANDA
Marketing start
2019-03-26
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-5092DDiscontinued by firm2026-07-31
excluded packagepackage68071-509268071-5092-2DDiscontinued 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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5092-22024-06-19C16284748780-1ba0f9c33-4857-a910-e053-dadaa90a0b85These 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
68071-5092-22023-01-30C16284748780-1ba0f9c33-4857-a910-e053-dadaa90a0b85These 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
68071-5092-22021-02-22C16284748780-1ba0f9c33-4857-a910-e053-dadaa90a0b85These 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
68071-5092-22021-01-29C16284748780-1ba0f9c33-4857-a910-e053-dadaa90a0b85These 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
68071-5092-26807150920212 TABLET, FILM COATED in 1 BOTTLE (68071-5092-2) 2019-10-240000-00-00NoNoCurrent