TADALAFIL

Product NDC
76519-1226
11-digit product format
765191226
Labeler code
76519
Product ID
76519-1226_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
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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct76519-1226IInactivated by FDA2026-09-14
excluded packagepackage76519-122676519-1226-3IInactivated by FDA2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76519-1226-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76519-1226-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76519-1226-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76519-1226-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76519-1226-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76519-1226-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76519-1226-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76519-1226-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76519-1226-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76519-1226-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76519-1226-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76519-1226-3557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage76519-1226-38af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage76519-1226-3834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage76519-1226-31332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage76519-1226-3fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage76519-1226-386f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage76519-1226-3bd6a592717d7…303034d00443…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090141-001TADALAFIL2.5MGTABLET / ORALAB12018-05-2284e616aacf4f…
2026-09-14 22:38:342026-08A090141-002TADALAFIL5MGTABLET / ORALAB12018-05-2284e616aacf4f…
2026-09-14 22:38:342026-08A090141-003TADALAFIL10MGTABLET / ORALAB12018-05-2284e616aacf4f…
2026-09-14 22:38:342026-08A090141-004TADALAFIL20MGTABLET / ORALAB12018-05-2284e616aacf4f…
2026-08-18 06:07:402026-07A090141-001TADALAFIL2.5MGTABLET / ORALAB12018-05-22caaa826d4ba7…
2026-08-18 06:07:402026-07A090141-002TADALAFIL5MGTABLET / ORALAB12018-05-22caaa826d4ba7…
2026-08-18 06:07:402026-07A090141-003TADALAFIL10MGTABLET / ORALAB12018-05-22caaa826d4ba7…
2026-08-18 06:07:402026-07A090141-004TADALAFIL20MGTABLET / ORALAB12018-05-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090141-001TADALAFIL2.5MGTABLET / ORALAB12018-05-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090141-002TADALAFIL5MGTABLET / ORALAB12018-05-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090141-003TADALAFIL10MGTABLET / ORALAB12018-05-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090141-004TADALAFIL20MGTABLET / ORALAB12018-05-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090141-001TADALAFIL2.5MGTABLET / ORALAB12018-05-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090141-002TADALAFIL5MGTABLET / ORALAB12018-05-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090141-003TADALAFIL10MGTABLET / ORALAB12018-05-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090141-004TADALAFIL20MGTABLET / ORALAB12018-05-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A090141-001TADALAFIL2.5MGTABLET / ORALAB12018-05-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090141-002TADALAFIL5MGTABLET / ORALAB12018-05-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090141-003TADALAFIL10MGTABLET / ORALAB12018-05-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090141-004TADALAFIL20MGTABLET / ORALAB12018-05-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090141-001TADALAFIL2.5MGTABLET / ORALAB12018-05-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090141-002TADALAFIL5MGTABLET / ORALAB12018-05-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090141-003TADALAFIL10MGTABLET / ORALAB12018-05-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090141-004TADALAFIL20MGTABLET / ORALAB12018-05-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090141-001TADALAFIL2.5MGTABLET / ORALAB12018-05-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090141-002TADALAFIL5MGTABLET / ORALAB12018-05-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090141-003TADALAFIL10MGTABLET / ORALAB12018-05-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090141-004TADALAFIL20MGTABLET / ORALAB12018-05-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090141-001TADALAFIL2.5MGTABLET / ORALAB12018-05-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090141-002TADALAFIL5MGTABLET / ORALAB12018-05-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090141-003TADALAFIL10MGTABLET / ORALAB12018-05-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090141-004TADALAFIL20MGTABLET / ORALAB12018-05-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090141-001TADALAFIL2.5MGTABLET / ORALAB12018-05-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090141-002TADALAFIL5MGTABLET / ORALAB12018-05-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090141-003TADALAFIL10MGTABLET / ORALAB12018-05-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090141-004TADALAFIL20MGTABLET / ORALAB12018-05-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090141-001TADALAFIL2.5MGTABLET / ORALAB12018-05-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090141-002TADALAFIL5MGTABLET / ORALAB12018-05-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090141-003TADALAFIL10MGTABLET / ORALAB12018-05-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090141-004TADALAFIL20MGTABLET / ORALAB12018-05-225bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090141-001AB1184e616aacf4f…
2026-09-14 22:38:342026-08A090141-002AB1184e616aacf4f…
2026-09-14 22:38:342026-08A090141-003AB1184e616aacf4f…
2026-09-14 22:38:342026-08A090141-004AB1184e616aacf4f…
2026-08-18 06:07:402026-07A090141-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A090141-002AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A090141-003AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A090141-004AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090141-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090141-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090141-003AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090141-004AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090141-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090141-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090141-003AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090141-004AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090141-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090141-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090141-003AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090141-004AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090141-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090141-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090141-003AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090141-004AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090141-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090141-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090141-003AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090141-004AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090141-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090141-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090141-003AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090141-004AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090141-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090141-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090141-003AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090141-004AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090141-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090141-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090141-003AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090141-004AB115bbf6a4d5a75…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12A090141-001PC2019-03-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090141-002PC2019-03-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090141-003PC2019-03-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090141-004PC2019-03-2674a2ff9319b5…
2019-12-14 00:12 UTC2019-12A090141-001PC2019-03-263f01610625f2…
2019-12-14 00:12 UTC2019-12A090141-002PC2019-03-263f01610625f2…
2019-12-14 00:12 UTC2019-12A090141-003PC2019-03-263f01610625f2…
2019-12-14 00:12 UTC2019-12A090141-004PC2019-03-263f01610625f2…
2019-09-15 20:21 UTC2019-09A090141-001PC2019-03-26b00525d2431f…
2019-09-15 20:21 UTC2019-09A090141-002PC2019-03-26b00525d2431f…
2019-09-15 20:21 UTC2019-09A090141-003PC2019-03-26b00525d2431f…
2019-09-15 20:21 UTC2019-09A090141-004PC2019-03-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A090141-001PC2019-03-26ea99ee380514…
2019-07-19 19:46 UTC2019-07A090141-002PC2019-03-26ea99ee380514…
2019-07-19 19:46 UTC2019-07A090141-003PC2019-03-26ea99ee380514…
2019-07-19 19:46 UTC2019-07A090141-004PC2019-03-26ea99ee380514…

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76519-1226-3TADALAFIL30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76519-1226TADALAFIL 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
76519-1226-37651912260330 TABLET, FILM COATED in 1 BOTTLE (76519-1226-3) 2019-05-210000-00-00NoNoCurrent