FDA.reportPublic FDA data

Tadalafil

Product NDC
42291-788
Requested package NDC
42291-788-30
11-digit product format
422910788
Labeler code
42291
Product ID
42291-788_c7026e67-7463-7fdc-e053-2a95a90a00d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA090141
Marketing category
ANDA
Marketing start
2018-10-09
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42291-78842291-788-30DDiscontinued by firm2026-08-03

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.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090141-001TADALAFIL2.5MGTABLET / ORALAB12018-05-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090141-002TADALAFIL5MGTABLET / ORALAB12018-05-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090141-003TADALAFIL10MGTABLET / ORALAB12018-05-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090141-004TADALAFIL20MGTABLET / ORALAB12018-05-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090141-001TADALAFIL2.5MGTABLET / ORALAB12018-05-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A090141-002TADALAFIL5MGTABLET / ORALAB12018-05-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A090141-003TADALAFIL10MGTABLET / ORALAB12018-05-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A090141-004TADALAFIL20MGTABLET / ORALAB12018-05-22d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090141-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090141-002AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090141-003AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090141-004AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090141-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A090141-002AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A090141-003AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A090141-004AB11d06236e962d9…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-788-30EA - Each42291-788f2fdff97-f9a7-4930-b593-3ecc6091660e12019-05-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-788-304229107883030 TABLET, FILM COATED in 1 BOTTLE (42291-788-30) 2018-10-090000-00-00NoNoCurrent