INDOMETHACIN

Product NDC
57664-120
11-digit product format
576640120
Labeler code
57664
Product ID
57664-120_45ad5425-58bc-46b3-8f6e-c01f4dd1d1e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
Caraco Pharmaceutical Laboratories, Ltd.
Application
ANDA091401
Marketing category
ANDA
Marketing start
2013-05-16
Marketing end
0000-00-00
Substance
INDOMETHACIN
Active strength
50 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57664-120DDiscontinued by firm2026-10-05
excluded packagepackage57664-12057664-120-08DDiscontinued by firm2026-10-05
excluded packagepackage57664-12057664-120-13DDiscontinued by firm2026-10-05
excluded packagepackage57664-12057664-120-18DDiscontinued by firm2026-10-05
excluded packagepackage57664-12057664-120-83DDiscontinued by firm2026-10-05
excluded packagepackage57664-12057664-120-88DDiscontinued by firm2026-10-05

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 3 · 132 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 packagepackage57664-120-88d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-120-83d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-120-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-120-18d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-120-13d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-120-88f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-120-83f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-120-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-120-18f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-120-13f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-120-882ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-120-832ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-120-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-120-182ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-120-132ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-120-88a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-120-83a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-120-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-120-18a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-120-13a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-120-88cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-120-83cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-120-08cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-120-18cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-120-13cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-120-88cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-120-83cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-120-08cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-120-18cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-120-13cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-120-88302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-120-83302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-120-08302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-120-18302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-120-13302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-120-88ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-120-83ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-120-08ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-120-18ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-120-13ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-120-880efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-120-830efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-120-080efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-120-180efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-120-130efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-120-88ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-120-83ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-120-08ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-120-18ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-120-13ad56d346431e…cc804d4bbf1e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A091401-001INDOMETHACININDOMETHACIN25MGCAPSULE / ORAL2013-03-28
A091401-002INDOMETHACININDOMETHACIN50MGCAPSULE / ORAL2013-03-28

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A091401-001INDOMETHACIN25MGCAPSULE / ORAL2013-03-2884e616aacf4f…
2026-09-14 22:38:342026-08A091401-002INDOMETHACIN50MGCAPSULE / ORAL2013-03-2884e616aacf4f…
2026-08-18 06:07:402026-07A091401-001INDOMETHACIN25MGCAPSULE / ORAL2013-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07A091401-002INDOMETHACIN50MGCAPSULE / ORAL2013-03-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091401-001INDOMETHACIN25MGCAPSULE / ORAL2013-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091401-002INDOMETHACIN50MGCAPSULE / ORAL2013-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091401-001INDOMETHACIN25MGCAPSULE / ORAL2013-03-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091401-002INDOMETHACIN50MGCAPSULE / ORAL2013-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A091401-001INDOMETHACIN25MGCAPSULE / ORAL2013-03-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091401-002INDOMETHACIN50MGCAPSULE / ORAL2013-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091401-001INDOMETHACIN25MGCAPSULE / ORAL2013-03-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091401-002INDOMETHACIN50MGCAPSULE / ORAL2013-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091401-001INDOMETHACIN25MGCAPSULE / ORAL2013-03-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091401-002INDOMETHACIN50MGCAPSULE / ORAL2013-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091401-001INDOMETHACIN25MGCAPSULE / ORAL2013-03-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091401-002INDOMETHACIN50MGCAPSULE / ORAL2013-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091401-001INDOMETHACIN25MGCAPSULE / ORAL2013-03-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091401-002INDOMETHACIN50MGCAPSULE / ORAL2013-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091401-001INDOMETHACIN25MGCAPSULE / ORAL2013-03-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091401-002INDOMETHACIN50MGCAPSULE / ORAL2013-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091401-001INDOMETHACIN25MGCAPSULE / ORAL2013-03-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091401-002INDOMETHACIN50MGCAPSULE / ORAL2013-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091401-001INDOMETHACIN25MGCAPSULE / ORAL2013-03-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A091401-002INDOMETHACIN50MGCAPSULE / ORAL2013-03-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091401-001INDOMETHACIN25MGCAPSULE / ORAL2013-03-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091401-002INDOMETHACIN50MGCAPSULE / ORAL2013-03-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091401-001INDOMETHACIN25MGCAPSULE / ORAL2013-03-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091401-002INDOMETHACIN50MGCAPSULE / ORAL2013-03-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091401-001INDOMETHACIN25MGCAPSULE / ORAL2013-03-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091401-002INDOMETHACIN50MGCAPSULE / ORAL2013-03-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091401-001INDOMETHACIN25MGCAPSULE / ORAL2013-03-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091401-002INDOMETHACIN50MGCAPSULE / ORAL2013-03-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091401-001INDOMETHACIN25MGCAPSULE / ORAL2013-03-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091401-002INDOMETHACIN50MGCAPSULE / ORAL2013-03-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091401-001INDOMETHACIN25MGCAPSULE / ORAL2013-03-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091401-002INDOMETHACIN50MGCAPSULE / ORAL2013-03-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091401-001INDOMETHACIN25MGCAPSULE / ORAL2013-03-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091401-002INDOMETHACIN50MGCAPSULE / ORAL2013-03-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091401-001INDOMETHACIN25MGCAPSULE / ORAL2013-03-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091401-002INDOMETHACIN50MGCAPSULE / ORAL2013-03-2874a2ff9319b5…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A091401-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091401-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091401-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091401-002AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]4
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MINDOMETHACIN CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]4
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3INDOMETHACIN CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKINDOMETHACIN CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]4
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SINDOMETHACIN CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAINDOMETHACIN CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]4
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INDOMETHACIN CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]4
METHYL ALCOHOLINACTIVE INGREDIENTY4S76JWI15INDOMETHACIN CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INDOMETHACIN CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]4
SHELLACINACTIVE INGREDIENT46N107B71OINDOMETHACIN CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2INDOMETHACIN CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-120INDOMETHACIN CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]4Legacy NDC20130516_c70b5045-706e-443a-9be1-d0bc3c598130.zip