INDOMETHACIN EXTENDED-RELEASE

Product NDC
52959-082
11-digit product format
529590082
Labeler code
52959
Product ID
52959-082_60cd54b1-0806-8b86-e053-2a91aa0a1458
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
INDOMETHACIN EXTENDED-RELEASE
Dosage form
CAPSULE
Route
ORAL
Labeler
H. J. Harkins Company inc.
Application
ANDA202706
Marketing category
ANDA
Marketing start
2017-02-21
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
2019-12-31
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 productproduct52959-082IInactivated by FDA2026-08-03
excluded packagepackage52959-08252959-082-05IInactivated by FDA2026-08-03
excluded packagepackage52959-08252959-082-07IInactivated by FDA2026-08-03
excluded packagepackage52959-08252959-082-14IInactivated by FDA2026-08-03
excluded packagepackage52959-08252959-082-15IInactivated by FDA2026-08-03
excluded packagepackage52959-08252959-082-20IInactivated by FDA2026-08-03
excluded packagepackage52959-08252959-082-21IInactivated by FDA2026-08-03
excluded packagepackage52959-08252959-082-30IInactivated by FDA2026-08-03
excluded packagepackage52959-08252959-082-60IInactivated by FDA2026-08-03

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 4 · 189 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 packagepackage52959-082-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-082-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-082-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-082-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-082-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-082-21d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-082-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-082-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-082-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-082-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-082-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-082-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-082-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-082-21f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-082-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-082-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-082-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-082-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-082-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-082-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-082-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-082-212ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-082-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-082-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-082-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-082-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-082-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-082-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-082-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-082-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-082-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-082-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-082-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-082-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-082-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-082-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-082-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-082-21cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-082-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-082-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-082-07cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-082-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-082-14cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-082-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-082-15cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-082-21cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-082-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-082-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-082-07302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-082-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-082-14302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-082-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-082-15302b2466d912…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…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
234b5275-84d6-d169-e08f-554a8aed3f0aProduct name320250717
9aaf7cf4-60c3-b44f-e302-fd8b276c713bProduct name220250107
c6b2f0e9-1a13-02e4-f789-55c724469f07Product name720171115
6e9718b9-62b9-458f-9408-30d688800922Product name120171103
d62774ab-b1b9-2d5c-924f-1948e411ae15Product name320170816
97c70338-ee37-4c78-a047-53ee1cd9b53dProduct name120150616

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-082-05INDOMETHACIN EXTENDED-RELEASE5 in 1 CONTAINERCAPSULE51
52959-082-07INDOMETHACIN EXTENDED-RELEASE7 in 1 CONTAINERCAPSULE71
52959-082-14INDOMETHACIN EXTENDED-RELEASE14 in 1 CONTAINERCAPSULE141
52959-082-15INDOMETHACIN EXTENDED-RELEASE15 in 1 CONTAINERCAPSULE151
52959-082-20INDOMETHACIN EXTENDED-RELEASE20 in 1 CONTAINERCAPSULE201
52959-082-21INDOMETHACIN EXTENDED-RELEASE21 in 1 CONTAINERCAPSULE211
52959-082-30INDOMETHACIN EXTENDED-RELEASE30 in 1 CONTAINERCAPSULE301
52959-082-60INDOMETHACIN EXTENDED-RELEASE60 in 1 CONTAINERCAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-082-07EA - Each52959-082645e6779-f78f-45f0-8ae5-d19248edab1d12018-01-12
52959-082-14EA - Each52959-08216c1e1e4-8ee8-48f8-816e-6b37d39d8e9612018-01-12
52959-082-15EA - Each52959-082557dfcbd-c3fb-47b9-9a0b-5b793a0488ef12018-01-12
52959-082-20EA - Each52959-082b80069bf-8c81-4e50-967e-c92e1fd6309412018-01-12
52959-082-21EA - Each52959-08264702707-73c3-47bf-85f5-070e2b8da9bb12018-01-12
52959-082-30EA - Each52959-082a71b71d8-3193-4696-bb4e-04e9412d6df112018-01-12
52959-082-60EA - Each52959-082c8be63e1-f64d-4e2c-afd6-578b962e2bce12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-082INDOMETHACIN EXTENDED-RELEASE CAPSULE [H. J. HARKINS COMPANY INC.]1Legacy NDC, 8 package rows20171222_60cd54b1-0805-8b86-e053-2a91aa0a1458.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310992indomethacin 75 MG Extended Release Oral CapsulePSN60cd54b1-0805-8b86-e053-2a91aa0a14581
310992indomethacin 75 MG Extended Release Oral CapsuleSCD60cd54b1-0805-8b86-e053-2a91aa0a14581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-082-05529590082055 in 1 CONTAINERHistorical
52959-082-07529590082077 in 1 CONTAINERHistorical
52959-082-145295900821414 in 1 CONTAINERHistorical
52959-082-155295900821515 in 1 CONTAINERHistorical
52959-082-205295900822020 in 1 CONTAINERHistorical
52959-082-215295900822121 in 1 CONTAINERHistorical
52959-082-305295900823030 in 1 CONTAINERHistorical
52959-082-605295900826060 in 1 CONTAINERHistorical