indomethacin

Product NDC
68382-293
11-digit product format
683820293
Labeler code
68382
Product ID
68382-293_22e405cf-6720-4017-bdd1-1b2c25e81f92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA090403
Marketing category
ANDA
Marketing start
2016-07-21
Marketing end
0000-00-00
Substance
INDOMETHACIN
Active strength
25 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
2021-12-31
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 productproduct68382-293DDiscontinued by firm2026-08-03
excluded packagepackage68382-29368382-293-01DDiscontinued by firm2026-08-03
excluded packagepackage68382-29368382-293-05DDiscontinued by firm2026-08-03
excluded packagepackage68382-29368382-293-10DDiscontinued by firm2026-08-03
excluded packagepackage68382-29368382-293-30DDiscontinued by firm2026-08-03

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 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 packagepackage68382-293-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-293-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-293-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-293-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-293-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-293-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-293-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-293-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68382-293-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68382-293-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68382-293-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68382-293-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68382-293-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68382-293-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68382-293-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68382-293-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68382-293-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68382-293-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68382-293-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68382-293-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68382-293-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68382-293-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68382-293-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68382-293-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68382-293-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68382-293-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68382-293-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68382-293-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68382-293-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68382-293-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68382-293-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68382-293-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68382-293-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68382-293-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68382-293-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68382-293-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68382-293-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68382-293-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68382-293-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68382-293-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68382-293-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68382-293-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68382-293-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68382-293-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68382-293-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68382-293-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68382-293-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68382-293-10557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090403-001INDOMETHACININDOMETHACIN25MGCAPSULE / ORALAB2010-11-15
A090403-002INDOMETHACININDOMETHACIN50MGCAPSULE / ORALAB2010-11-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A090403-001AB
A090403-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-15bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-15782e0a99824c…
2021-12-28 21:50 UTC2021-12A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-15782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090403-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090403-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090403-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090403-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090403-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090403-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090403-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090403-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090403-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090403-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090403-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090403-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090403-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090403-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090403-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090403-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090403-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090403-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090403-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090403-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090403-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090403-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090403-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090403-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090403-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090403-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090403-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090403-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090403-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090403-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090403-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090403-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090403-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090403-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090403-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090403-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090403-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090403-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090403-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090403-002AB1782e0a99824c…

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-293-01EA - Each68382-29327d3775b-f8ac-4559-ab69-45b2e54af11912016-10-06
68382-293-10EA - Each68382-2935b200148-6ff3-4675-a908-34654fb814cc12016-10-06

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197817indomethacin 25 MG Oral CapsulePSN50d853fa-cdaa-488a-e054-00144ff88e883
197817indomethacin 25 MG Oral CapsuleSCD50d853fa-cdaa-488a-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-293-0168382029301100 CAPSULE in 1 BOTTLE (68382-293-01) 100 capsule2016-07-210000-00-00NoNoCurrent
68382-293-0568382029305500 CAPSULE in 1 BOTTLE (68382-293-05) 500 capsule2016-07-210000-00-00NoNoCurrent
68382-293-10683820293101000 CAPSULE in 1 BOTTLE (68382-293-10) 1000 capsule2016-07-210000-00-00NoNoCurrent
68382-293-306838202933010 CAPSULE in 1 BLISTER PACK (68382-293-30) 10 capsule2016-07-210000-00-00NoNoCurrent