Home NDC 42211-202 Tivorbex
Product NDC 42211-202
11-digit product format 422110202
Labeler code 42211
Product ID 42211-202_8a792cbe-8874-4655-a1e7-ca9007eee950
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name indomethacin
Dosage form CAPSULE
Route ORAL
Labeler Iroko Pharmaceuticals, LLC
Application NDA204768
Marketing category NDA
Marketing start 2015-07-06
Marketing end 0000-00-00
Substance INDOMETHACIN
Active strength 40 mg/1
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2019-12-31
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 2 · 105 matching rows.
View current auxiliary records. · View the auxiliary file history.
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…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded indomethacin ACTIVE INGREDIENT XXE1CET956 TIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC] 3 indomethacin ACTIVE MOIETY XXE1CET956 TIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 TIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK TIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L TIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J TIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC] 3 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI TIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42211-202 TIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC] 7 Legacy NDC, 6 package rows 20180221_04ca474c-798e-43dd-be7a-1b36720e6a3d.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 42211-202-23 42211020223 30 in 1 BOTTLE Historical 42211-202-29 42211020229 90 in 1 BOTTLE Historical 42211-202-42 42211020242 2 in 1 BLISTER PACK Historical 42211-202-43 42211020243 3 in 1 BLISTER PACK Historical