Home NDC 71205-418 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 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 Dataset Scope Package NDC excluded product product excluded package package 71205-418-90 excluded package package 71205-418-60 excluded package package 71205-418-30
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090141-001 TADALAFIL TADALAFIL 2.5MG TABLET / ORAL AB1 2018-05-22 A090141-002 TADALAFIL TADALAFIL 5MG TABLET / ORAL AB1 2018-05-22 A090141-003 TADALAFIL TADALAFIL 10MG TABLET / ORAL AB1 2018-05-22 A090141-004 TADALAFIL TADALAFIL 20MG TABLET / ORAL AB1 2018-05-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A090141-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2018-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090141-002 TADALAFIL 5MG TABLET / ORAL AB1 2018-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090141-003 TADALAFIL 10MG TABLET / ORAL AB1 2018-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090141-004 TADALAFIL 20MG TABLET / ORAL AB1 2018-05-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090141-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2018-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090141-002 TADALAFIL 5MG TABLET / ORAL AB1 2018-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090141-003 TADALAFIL 10MG TABLET / ORAL AB1 2018-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090141-004 TADALAFIL 20MG TABLET / ORAL AB1 2018-05-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090141-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2018-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090141-002 TADALAFIL 5MG TABLET / ORAL AB1 2018-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090141-003 TADALAFIL 10MG TABLET / ORAL AB1 2018-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090141-004 TADALAFIL 20MG TABLET / ORAL AB1 2018-05-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090141-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2018-05-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090141-002 TADALAFIL 5MG TABLET / ORAL AB1 2018-05-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090141-003 TADALAFIL 10MG TABLET / ORAL AB1 2018-05-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090141-004 TADALAFIL 20MG TABLET / ORAL AB1 2018-05-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090141-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2018-05-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090141-002 TADALAFIL 5MG TABLET / ORAL AB1 2018-05-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090141-003 TADALAFIL 10MG TABLET / ORAL AB1 2018-05-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090141-004 TADALAFIL 20MG TABLET / ORAL AB1 2018-05-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090141-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2018-05-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090141-002 TADALAFIL 5MG TABLET / ORAL AB1 2018-05-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090141-003 TADALAFIL 10MG TABLET / ORAL AB1 2018-05-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090141-004 TADALAFIL 20MG TABLET / ORAL AB1 2018-05-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090141-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2018-05-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090141-002 TADALAFIL 5MG TABLET / ORAL AB1 2018-05-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090141-003 TADALAFIL 10MG TABLET / ORAL AB1 2018-05-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090141-004 TADALAFIL 20MG TABLET / ORAL AB1 2018-05-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090141-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2018-05-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090141-002 TADALAFIL 5MG TABLET / ORAL AB1 2018-05-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090141-003 TADALAFIL 10MG TABLET / ORAL AB1 2018-05-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090141-004 TADALAFIL 20MG TABLET / ORAL AB1 2018-05-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090141-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2018-05-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090141-002 TADALAFIL 5MG TABLET / ORAL AB1 2018-05-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090141-003 TADALAFIL 10MG TABLET / ORAL AB1 2018-05-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090141-004 TADALAFIL 20MG TABLET / ORAL AB1 2018-05-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090141-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2018-05-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090141-002 TADALAFIL 5MG TABLET / ORAL AB1 2018-05-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090141-003 TADALAFIL 10MG TABLET / ORAL AB1 2018-05-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090141-004 TADALAFIL 20MG TABLET / ORAL AB1 2018-05-22 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Observed Orange Book exclusivity history# DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-418 TADALAFIL TABLET, FILM COATED [PROFICIENT RX LP] 1 Legacy NDC 20200320_d16b3ad6-7c3f-4379-b179-b5b6dab29a58.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71205-418-30 71205041830 30 TABLET, FILM COATED in 1 BOTTLE (71205-418-30) 2020-03-04 0000-00-00 No No Current 71205-418-60 71205041860 60 TABLET, FILM COATED in 1 BOTTLE (71205-418-60) 2020-03-04 0000-00-00 No No Current 71205-418-90 71205041890 90 TABLET, FILM COATED in 1 BOTTLE (71205-418-90) 2020-03-04 0000-00-00 No No Current