FDA.reportPublic FDA data

Tadalafil

Product NDC
61919-889
Requested package NDC
61919-889-30
11-digit product format
619190889
Labeler code
61919
Product ID
61919-889_8b34e71c-fb67-3edf-e053-2a95a90a40fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA209908
Marketing category
ANDA
Marketing start
2019-06-13
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
2020-12-31
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 packagepackage61919-88961919-889-30DDiscontinued 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-889-30EA - Each61919-889d51e5154-0c8e-444e-ab52-1adbc528193612019-08-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-889-306191908893030 TABLET, FILM COATED in 1 BOTTLE (61919-889-30) 2019-06-130000-00-00NoNoCurrent