Tadalafil

Product NDC
71205-418
11-digit product format
712050418
Labeler code
71205
Product ID
71205-418_d16b3ad6-7c3f-4379-b179-b5b6dab29a58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090141
Marketing category
ANDA
Marketing start
2018-09-27
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
2021-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71205-418DDiscontinued by firm2026-09-14
excluded packagepackage71205-41871205-418-30DDiscontinued by firm2026-09-14
excluded packagepackage71205-41871205-418-60DDiscontinued by firm2026-09-14
excluded packagepackage71205-41871205-418-90DDiscontinued by firm2026-09-14

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 · 4 matching rows.

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

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage71205-418-90
excluded packagepackage71205-418-60
excluded packagepackage71205-418-30

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b86a08b7-54cc-440b-ad4a-3e530ccd8324Product name620230421
7a02e74a-2844-42af-84a8-96bae57351cfProduct name120230313
928d249c-35c3-4d88-a9ef-cf2f2e31b96fProduct name120220706
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-418-30EA - Each71205-4184130e6b5-0999-43e8-b06b-111fb212075112020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-418TADALAFIL TABLET, FILM COATED [PROFICIENT RX LP]1Legacy NDC20200320_d16b3ad6-7c3f-4379-b179-b5b6dab29a58.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-418-307120504183030 TABLET, FILM COATED in 1 BOTTLE (71205-418-30) 2020-03-040000-00-00NoNoCurrent
71205-418-607120504186060 TABLET, FILM COATED in 1 BOTTLE (71205-418-60) 2020-03-040000-00-00NoNoCurrent
71205-418-907120504189090 TABLET, FILM COATED in 1 BOTTLE (71205-418-90) 2020-03-040000-00-00NoNoCurrent