FDA.reportPublic FDA data

TADALAFIL

Product NDC
76519-1227
11-digit product format
765191227
Labeler code
76519
Product ID
76519-1227_8c687cd7-bda4-f812-e053-2995a90abfdd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TADALAFIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA090141
Marketing category
ANDA
Marketing start
2019-05-21
Marketing end
0000-00-00
Substance
TADALAFIL
Active strength
10 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct76519-1227IInactivated by FDA2026-07-31
excluded packagepackage76519-122776519-1227-3IInactivated 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
A090141-001TADALAFILTADALAFIL2.5MGTABLET / ORALAB12018-05-22
A090141-002TADALAFILTADALAFIL5MGTABLET / ORALAB12018-05-22
A090141-003TADALAFILTADALAFIL10MGTABLET / ORALAB12018-05-22
A090141-004TADALAFILTADALAFIL20MGTABLET / ORALAB12018-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090141-001AB1
A090141-002AB1
A090141-003AB1
A090141-004AB1

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 22:54:322026-06A090141-001TADALAFIL2.5MGTABLET / ORALAB12018-05-22a50c72e98297…
2026-08-01 22:54:322026-06A090141-002TADALAFIL5MGTABLET / ORALAB12018-05-22a50c72e98297…
2026-08-01 22:54:322026-06A090141-003TADALAFIL10MGTABLET / ORALAB12018-05-22a50c72e98297…
2026-08-01 22:54:322026-06A090141-004TADALAFIL20MGTABLET / ORALAB12018-05-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090141-001AB11a50c72e98297…
2026-08-01 22:54:322026-06A090141-002AB11a50c72e98297…
2026-08-01 22:54:322026-06A090141-003AB11a50c72e98297…
2026-08-01 22:54:322026-06A090141-004AB11a50c72e98297…

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
76519-1227-32022-01-28C16284748780-1d6a99b39-ebe6-a426-e053-dadaa90af4c21225/1226/1227 TADALAFIL 5/10/20 MG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76519-1227-3TADALAFIL30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76519-1227TADALAFIL TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 1 package rows20190725_8c687cd7-bda3-f812-e053-2995a90abfdd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSN8c687cd7-bda3-f812-e053-2995a90abfdd1
402019tadalafil 20 MG Oral TabletPSN8c687cd7-bda3-f812-e053-2995a90abfdd1
403957tadalafil 5 MG Oral TabletPSN8c687cd7-bda3-f812-e053-2995a90abfdd1
484814tadalafil 10 MG Oral TabletSCD8c687cd7-bda3-f812-e053-2995a90abfdd1
402019tadalafil 20 MG Oral TabletSCD8c687cd7-bda3-f812-e053-2995a90abfdd1
403957tadalafil 5 MG Oral TabletSCD8c687cd7-bda3-f812-e053-2995a90abfdd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76519-1227-37651912270330 TABLET, FILM COATED in 1 BOTTLE (76519-1227-3) 2019-05-210000-00-00NoNoCurrent