Indomethacin

Product NDC
50742-234
11-digit product format
507420234
Labeler code
50742
Product ID
50742-234_cd5d7602-7768-40e8-946c-246cdaff0afc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA204853
Marketing category
ANDA
Marketing start
2017-05-08
Marketing end
0000-00-00
Substance
INDOMETHACIN
Active strength
75 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
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50742-234DDiscontinued by firm2026-08-07
excluded packagepackage50742-23450742-234-01DDiscontinued by firm2026-08-07
excluded packagepackage50742-23450742-234-10DDiscontinued by firm2026-08-07
excluded packagepackage50742-23450742-234-60DDiscontinued by firm2026-08-07
excluded packagepackage50742-23450742-234-90DDiscontinued by firm2026-08-07

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 · 60 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50742-234-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50742-234-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50742-234-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50742-234-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50742-234-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50742-234-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50742-234-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50742-234-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50742-234-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50742-234-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50742-234-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50742-234-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50742-234-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50742-234-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50742-234-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50742-234-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50742-234-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50742-234-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50742-234-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50742-234-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50742-234-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50742-234-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50742-234-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50742-234-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50742-234-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50742-234-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50742-234-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50742-234-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50742-234-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50742-234-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50742-234-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50742-234-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50742-234-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50742-234-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50742-234-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50742-234-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50742-234-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50742-234-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50742-234-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50742-234-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50742-234-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50742-234-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50742-234-90367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50742-234-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50742-234-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50742-234-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50742-234-90557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50742-234-60557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204853-001INDOMETHACININDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A204853-001AB

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-083f01610625f2…
2019-09-15 20:21 UTC2019-09A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204853-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2017-05-08cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204853-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204853-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204853-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204853-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204853-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204853-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204853-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204853-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204853-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204853-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204853-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204853-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204853-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204853-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204853-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204853-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204853-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204853-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204853-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204853-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204853-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A204853-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204853-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204853-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204853-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A204853-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204853-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204853-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204853-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204853-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204853-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204853-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204853-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204853-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A204853-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A204853-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204853-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204853-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204853-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204853-001AB1cb3db0bc1861…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50742-234-0150742023401100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-234-01) 2017-05-080000-00-00NoNoCurrent
50742-234-10507420234101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-234-10) 2017-05-080000-00-00NoNoCurrent
50742-234-605074202346060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-234-60) 2017-05-080000-00-00NoNoCurrent
50742-234-905074202349090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-234-90) 2017-05-080000-00-00NoNoCurrent