Home NDC 50268-738 Tadalafil
Product NDC 50268-738
11-digit product format 502680738
Labeler code 50268
Product ID 50268-738_df22addc-06e7-9804-e053-2a95a90a6c3f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tadalafil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AvPAK
Application ANDA210069
Marketing category ANDA
Marketing start 2020-02-26
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 2023-12-31
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.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50268-738-13 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50268-738-13 f5e01cc5f278…a2eaf40c39c3…
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 A210069-001 TADALAFIL TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 A210069-002 TADALAFIL TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 A210069-003 TADALAFIL TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 A210069-004 TADALAFIL TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26
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 A210069-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210069-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210069-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210069-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210069-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210069-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210069-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210069-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210069-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210069-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210069-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210069-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210069-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210069-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210069-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210069-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210069-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210069-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210069-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210069-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210069-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210069-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210069-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210069-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210069-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210069-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210069-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210069-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210069-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210069-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210069-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210069-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210069-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210069-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210069-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210069-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210069-001 TADALAFIL 2.5MG TABLET / ORAL AB1 2019-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210069-002 TADALAFIL 5MG TABLET / ORAL AB1 2019-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210069-003 TADALAFIL 10MG TABLET / ORAL AB1 2019-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210069-004 TADALAFIL 20MG TABLET / ORAL AB1 2019-03-26 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-738 TADALAFIL TABLET, FILM COATED [AVPAK] 6 Legacy NDC 20250112_9f7dfabf-40dc-d433-e053-2a95a90ac784.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tadalafil TADALAFIL Dr.Reddys Laboratories Inc 22b8a2e3-d1b8-f193-45fa-77cc62a1b941 2020-01-30 Warnings, Adverse reactions Exact identifier application applno (ANDA): 210069 application number: ANDA210069
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50268-738-13 50268073813 30 BLISTER PACK in 1 BOX (50268-738-13) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-738-11) 30 blister pack 2020-02-26 0000-00-00 No No Current