Home NDC 69597-350 Tivorbex
Product NDC 69597-350
11-digit product format 695970350
Labeler code 69597
Product ID 69597-350_54f610e1-963d-4998-a7f1-f0d53532422d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name indomethacin
Dosage form CAPSULE
Route ORAL
Labeler Basiem
Application NDA204768
Marketing category NDA
Marketing start 2020-01-03
Marketing end 2022-11-01
Substance INDOMETHACIN
Active strength 20 mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 24 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 69597-350-30 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 69597-350-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 69597-350-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 69597-350-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 69597-350-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 69597-350-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69597-350-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69597-350-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69597-350-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 69597-350-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 69597-350-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 69597-350-30 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N204768-001 TIVORBEX INDOMETHACIN 20MG CAPSULE / ORAL RLD 2014-02-24 N204768-002 TIVORBEX INDOMETHACIN 40MG CAPSULE / ORAL RLD 2014-02-24
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N204768-001 8734847 2030-04-23 Drug product 2014-05-27 N204768-001 8992982 2030-04-23 Drug product 2015-04-03 N204768-001 9089471 2030-04-23 U-55 2015-07-27 N204768-002 8734847 2030-04-23 Drug product 2014-05-27 N204768-002 8992982 2030-04-23 Drug product 2015-04-03 N204768-002 9089471 2030-04-23 U-55 2015-07-27
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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 N204768-001 TIVORBEX 20MG CAPSULE / ORAL RLD 2014-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204768-002 TIVORBEX 40MG CAPSULE / ORAL RLD 2014-02-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204768-001 TIVORBEX 20MG CAPSULE / ORAL RLD 2014-02-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204768-002 TIVORBEX 40MG CAPSULE / ORAL RLD 2014-02-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204768-001 TIVORBEX 20MG CAPSULE / ORAL RLD 2014-02-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204768-002 TIVORBEX 40MG CAPSULE / ORAL RLD 2014-02-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204768-001 TIVORBEX 20MG CAPSULE / ORAL RLD 2014-02-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204768-002 TIVORBEX 40MG CAPSULE / ORAL RLD 2014-02-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204768-001 TIVORBEX 20MG CAPSULE / ORAL RLD 2014-02-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204768-002 TIVORBEX 40MG CAPSULE / ORAL RLD 2014-02-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204768-001 TIVORBEX 20MG CAPSULE / ORAL RLD 2014-02-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204768-002 TIVORBEX 40MG CAPSULE / ORAL RLD 2014-02-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204768-001 TIVORBEX 20MG CAPSULE / ORAL RLD 2014-02-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204768-002 TIVORBEX 40MG CAPSULE / ORAL RLD 2014-02-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204768-001 TIVORBEX 20MG CAPSULE / ORAL RLD 2014-02-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204768-002 TIVORBEX 40MG CAPSULE / ORAL RLD 2014-02-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204768-001 TIVORBEX 20MG CAPSULE / ORAL RLD 2014-02-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204768-002 TIVORBEX 40MG CAPSULE / ORAL RLD 2014-02-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204768-001 TIVORBEX 20MG CAPSULE / ORAL RLD 2014-02-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204768-002 TIVORBEX 40MG CAPSULE / ORAL RLD 2014-02-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204768-001 TIVORBEX 20MG CAPSULE / ORAL RLD 2014-02-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204768-002 TIVORBEX 40MG CAPSULE / ORAL RLD 2014-02-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204768-001 TIVORBEX 20MG CAPSULE / ORAL RLD 2014-02-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204768-002 TIVORBEX 40MG CAPSULE / ORAL RLD 2014-02-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204768-001 TIVORBEX 20MG CAPSULE / ORAL RLD 2014-02-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204768-002 TIVORBEX 40MG CAPSULE / ORAL RLD 2014-02-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204768-001 TIVORBEX 20MG CAPSULE / ORAL RLD 2014-02-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N204768-002 TIVORBEX 40MG CAPSULE / ORAL RLD 2014-02-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204768-001 TIVORBEX 20MG CAPSULE / ORAL RLD 2014-02-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204768-002 TIVORBEX 40MG CAPSULE / ORAL RLD 2014-02-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204768-001 TIVORBEX 20MG CAPSULE / ORAL RLD 2014-02-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N204768-002 TIVORBEX 40MG CAPSULE / ORAL RLD 2014-02-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204768-001 TIVORBEX 20MG CAPSULE / ORAL RLD 2014-02-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N204768-002 TIVORBEX 40MG CAPSULE / ORAL RLD 2014-02-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204768-001 TIVORBEX 20MG CAPSULE / ORAL RLD 2014-02-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N204768-002 TIVORBEX 40MG CAPSULE / ORAL RLD, RS 2014-02-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204768-001 TIVORBEX 20MG CAPSULE / ORAL RLD 2014-02-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N204768-002 TIVORBEX 40MG CAPSULE / ORAL RLD 2014-02-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204768-001 TIVORBEX 20MG CAPSULE / ORAL RLD 2014-02-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N204768-002 TIVORBEX 40MG CAPSULE / ORAL RLD 2014-02-24 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 7 · 246 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N204768-001 8734847 2030-04-23 Drug product 2014-05-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204768-001 8992982 2030-04-23 Drug product 2015-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204768-001 9089471 2030-04-23 U-55 2015-07-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204768-002 8734847 2030-04-23 Drug product 2014-05-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204768-002 8992982 2030-04-23 Drug product 2015-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204768-002 9089471 2030-04-23 U-55 2015-07-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204768-001 8734847 2030-04-23 Drug product 2014-05-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204768-001 8992982 2030-04-23 Drug product 2015-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204768-001 9089471 2030-04-23 U-55 2015-07-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204768-002 8734847 2030-04-23 Drug product 2014-05-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204768-002 8992982 2030-04-23 Drug product 2015-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204768-002 9089471 2030-04-23 U-55 2015-07-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204768-001 8734847 2030-04-23 Drug product 2014-05-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204768-001 8992982 2030-04-23 Drug product 2015-04-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204768-001 9089471 2030-04-23 U-55 2015-07-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204768-002 8734847 2030-04-23 Drug product 2014-05-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204768-002 8992982 2030-04-23 Drug product 2015-04-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204768-002 9089471 2030-04-23 U-55 2015-07-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204768-001 8734847 2030-04-23 Drug product 2014-05-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204768-001 8992982 2030-04-23 Drug product 2015-04-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204768-001 9089471 2030-04-23 U-55 2015-07-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204768-002 8734847 2030-04-23 Drug product 2014-05-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204768-002 8992982 2030-04-23 Drug product 2015-04-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204768-002 9089471 2030-04-23 U-55 2015-07-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204768-001 8734847 2030-04-23 Drug product 2014-05-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204768-001 8992982 2030-04-23 Drug product 2015-04-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204768-001 9089471 2030-04-23 U-55 2015-07-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204768-002 8734847 2030-04-23 Drug product 2014-05-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204768-002 8992982 2030-04-23 Drug product 2015-04-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204768-002 9089471 2030-04-23 U-55 2015-07-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204768-001 8734847 2030-04-23 Drug product 2014-05-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204768-001 8992982 2030-04-23 Drug product 2015-04-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204768-001 9089471 2030-04-23 U-55 2015-07-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204768-002 8734847 2030-04-23 Drug product 2014-05-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204768-002 8992982 2030-04-23 Drug product 2015-04-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204768-002 9089471 2030-04-23 U-55 2015-07-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204768-001 8734847 2030-04-23 Drug product 2014-05-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204768-001 8992982 2030-04-23 Drug product 2015-04-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204768-001 9089471 2030-04-23 U-55 2015-07-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204768-002 8734847 2030-04-23 Drug product 2014-05-27 2680178bc6a6…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69597-350-30 69597035030 30 CAPSULE in 1 BOTTLE (69597-350-30) 30 capsule 2020-01-03 0000-00-00 No No Current