Indomethacin extended-release

Product NDC
71335-0137
11-digit product format
713350137
Labeler code
71335
Product ID
71335-0137_3e51d610-e593-45e4-8776-b00340f05e7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin extended-release
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202706
Marketing category
ANDA
Marketing start
2015-10-05
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
2022-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-0137DDiscontinued by firm2026-08-07
excluded packagepackage71335-013771335-0137-1DDiscontinued by firm2026-08-07
excluded packagepackage71335-013771335-0137-2DDiscontinued by firm2026-08-07
excluded packagepackage71335-013771335-0137-3DDiscontinued by firm2026-08-07
excluded packagepackage71335-013771335-0137-4DDiscontinued by firm2026-08-07
excluded packagepackage71335-013771335-0137-5DDiscontinued by firm2026-08-07
excluded packagepackage71335-013771335-0137-6DDiscontinued by firm2026-08-07
excluded packagepackage71335-013771335-0137-7DDiscontinued by firm2026-08-07
excluded packagepackage71335-013771335-0137-8DDiscontinued 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 2 · 108 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 packagepackage71335-0137-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0137-7d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0137-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0137-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0137-8d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0137-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0137-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0137-6d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0137-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0137-7f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0137-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0137-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0137-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0137-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0137-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0137-6f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0137-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0137-72ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0137-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0137-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0137-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0137-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0137-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0137-62ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0137-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0137-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0137-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0137-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0137-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0137-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0137-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0137-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0137-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0137-7cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0137-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0137-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0137-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0137-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0137-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0137-6cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0137-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0137-7cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0137-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0137-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0137-8cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0137-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0137-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0137-6cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0137-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0137-7302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0137-5302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0137-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0137-8302b2466d912…e7b80fea0513…

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
A202706-001INDOMETHACININDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-05

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 UTC2026-02A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2015-10-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2015-10-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2015-10-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2015-10-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2015-10-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2015-10-053f01610625f2…
2019-09-15 20:21 UTC2019-09A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2015-10-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORALAB2015-10-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202706-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2015-10-05cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A202706-001AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202706-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A202706-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202706-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202706-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202706-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202706-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202706-001AB1ea99ee380514…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0137-17133501370130 CAPSULE in 1 BOTTLE (71335-0137-1) 30 capsule2017-08-080000-00-00NoNoCurrent
71335-0137-27133501370260 CAPSULE in 1 BOTTLE (71335-0137-2) 60 capsule2017-08-080000-00-00NoNoCurrent
71335-0137-37133501370314 CAPSULE in 1 BOTTLE (71335-0137-3) 14 capsule2017-08-080000-00-00NoNoCurrent
71335-0137-47133501370410 CAPSULE in 1 BOTTLE (71335-0137-4) 10 capsule2017-08-080000-00-00NoNoCurrent
71335-0137-5713350137057 CAPSULE in 1 BOTTLE (71335-0137-5) 7 capsule2017-08-080000-00-00NoNoCurrent
71335-0137-67133501370615 CAPSULE in 1 BOTTLE (71335-0137-6) 15 capsule2017-08-080000-00-00NoNoCurrent
71335-0137-77133501370720 CAPSULE in 1 BOTTLE (71335-0137-7) 20 capsule2017-08-080000-00-00NoNoCurrent
71335-0137-87133501370890 CAPSULE in 1 BOTTLE (71335-0137-8) 90 capsule2017-08-080000-00-00NoNoCurrent