Home NDC 33342-265 Tadalafil
Product NDC 33342-265
11-digit product format 333420265
Labeler code 33342
Product ID 33342-265_1bc04765-18de-40fc-a680-fbe55aad1cf2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tadalafil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA207244
Marketing category ANDA
Marketing start 2019-10-08
Substance TADALAFIL
Active strength 2.5 mg/1
Pharmacologic classes Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 A207244-001 TADALAFIL TADALAFIL 2.5MG TABLET / ORAL AB1 2019-10-07 A207244-002 TADALAFIL TADALAFIL 5MG TABLET / ORAL AB1 2019-10-07 A207244-003 TADALAFIL TADALAFIL 10MG TABLET / ORAL AB1 2019-10-07 A207244-004 TADALAFIL TADALAFIL 20MG TABLET / ORAL AB1 2019-10-07
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 · 164 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 A207244-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-10-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207244-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-10-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207244-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-10-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207244-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-10-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207244-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-10-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207244-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-10-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207244-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-10-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207244-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-10-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207244-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207244-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207244-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207244-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-10-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207244-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207244-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207244-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207244-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-10-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207244-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207244-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207244-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207244-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-10-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207244-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-10-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207244-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-10-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207244-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-10-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207244-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-10-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207244-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-10-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207244-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-10-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207244-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-10-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207244-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-10-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207244-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-10-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207244-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-10-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207244-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-10-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207244-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-10-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207244-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-10-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207244-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-10-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207244-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-10-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207244-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-10-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207244-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-10-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207244-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-10-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207244-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-10-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207244-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-10-07 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tadalafil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TADALAFIL 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 742SXX0ICT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 402019 Internal RxNorm lookup 403957 Internal RxNorm lookup 484814 Internal RxNorm lookup 757707 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 33342-265-07 Tadalafil 30 in 1 BOTTLE TABLET, FILM COATED 30 4 33342-265-44 Tadalafil 1000 in 1 BOTTLE TABLET, FILM COATED 1000 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-265 TADALAFIL TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 3 Current NDC, Legacy NDC, 2 package rows 20250323_4348b7db-e5b2-4e87-8cdd-674797a18890.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 33342-265-07 33342026507 30 TABLET, FILM COATED in 1 BOTTLE (33342-265-07) 2019-10-08 0000-00-00 No No Current 33342-265-44 33342026544 1000 TABLET, FILM COATED in 1 BOTTLE (33342-265-44) 2025-04-17 No No Current