INDOMETHACIN

Product NDC
61919-487
11-digit product format
619190487
Labeler code
61919
Product ID
61919-487_8f04029c-263e-4334-b501-76525d049a31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
INDOMETHACIN
Dosage form
CAPSULE
Route
ORAL
Labeler
DirectRX
Application
NDA018851
Marketing category
NDA
Marketing start
2015-01-01
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-487IInactivated by FDA2026-08-17
excluded packagepackage61919-48761919-487-30IInactivated by FDA2026-08-17
excluded packagepackage61919-48761919-487-60IInactivated by FDA2026-08-17

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 · 66 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 packagepackage61919-487-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-487-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-487-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-487-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-487-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-487-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-487-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-487-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-487-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-487-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-487-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-487-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-487-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-487-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-487-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-487-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-487-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-487-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-487-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-487-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-487-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-487-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-487-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-487-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-487-608af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-487-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-487-60834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-487-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-487-601332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-487-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage61919-487-60fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage61919-487-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61919-487-6086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61919-487-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61919-487-60bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61919-487-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage61919-487-608dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage61919-487-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage61919-487-60e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage61919-487-30e2bbac7714bc…27bdfed8d636…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N018851-001INDOMETHACININDOMETHACIN25MGCAPSULE / ORAL1984-05-18
N018851-002INDOMETHACININDOMETHACIN50MGCAPSULE / ORAL1984-05-18

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018851-001INDOMETHACIN25MGCAPSULE / ORAL1984-05-18caaa826d4ba7…
2026-08-18 06:07:402026-07N018851-002INDOMETHACIN50MGCAPSULE / ORAL1984-05-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018851-001INDOMETHACIN25MGCAPSULE / ORAL1984-05-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018851-002INDOMETHACIN50MGCAPSULE / ORAL1984-05-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018851-001INDOMETHACIN25MGCAPSULE / ORAL1984-05-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018851-002INDOMETHACIN50MGCAPSULE / ORAL1984-05-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N018851-001INDOMETHACIN25MGCAPSULE / ORAL1984-05-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018851-002INDOMETHACIN50MGCAPSULE / ORAL1984-05-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018851-001INDOMETHACIN25MGCAPSULE / ORAL1984-05-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018851-002INDOMETHACIN50MGCAPSULE / ORAL1984-05-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018851-001INDOMETHACIN25MGCAPSULE / ORAL1984-05-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018851-002INDOMETHACIN50MGCAPSULE / ORAL1984-05-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018851-001INDOMETHACIN25MGCAPSULE / ORAL1984-05-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018851-002INDOMETHACIN50MGCAPSULE / ORAL1984-05-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018851-001INDOMETHACIN25MGCAPSULE / ORAL1984-05-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018851-002INDOMETHACIN50MGCAPSULE / ORAL1984-05-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018851-001INDOMETHACIN25MGCAPSULE / ORAL1984-05-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018851-002INDOMETHACIN50MGCAPSULE / ORAL1984-05-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018851-001INDOMETHACIN25MGCAPSULE / ORAL1984-05-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018851-002INDOMETHACIN50MGCAPSULE / ORAL1984-05-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018851-001INDOMETHACIN25MGCAPSULE / ORAL1984-05-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N018851-002INDOMETHACIN50MGCAPSULE / ORAL1984-05-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018851-001INDOMETHACIN25MGCAPSULE / ORAL1984-05-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018851-002INDOMETHACIN50MGCAPSULE / ORAL1984-05-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018851-001INDOMETHACIN25MGCAPSULE / ORAL1984-05-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018851-002INDOMETHACIN50MGCAPSULE / ORAL1984-05-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018851-001INDOMETHACIN25MGCAPSULE / ORAL1984-05-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018851-002INDOMETHACIN50MGCAPSULE / ORAL1984-05-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018851-001INDOMETHACIN25MGCAPSULE / ORAL1984-05-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018851-002INDOMETHACIN50MGCAPSULE / ORAL1984-05-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018851-001INDOMETHACIN25MGCAPSULE / ORAL1984-05-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018851-002INDOMETHACIN50MGCAPSULE / ORAL1984-05-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018851-001INDOMETHACIN25MGCAPSULE / ORAL1984-05-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018851-002INDOMETHACIN50MGCAPSULE / ORAL1984-05-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018851-001INDOMETHACIN25MGCAPSULE / ORAL1984-05-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018851-002INDOMETHACIN50MGCAPSULE / ORAL1984-05-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018851-001INDOMETHACIN25MGCAPSULE / ORALAB1984-05-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018851-002INDOMETHACIN50MGCAPSULE / ORALAB1984-05-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018851-001INDOMETHACIN25MGCAPSULE / ORAL1984-05-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N018851-002INDOMETHACIN50MGCAPSULE / ORAL1984-05-18bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N018851-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018851-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12N018851-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N018851-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N018851-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N018851-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018851-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N018851-002AB1ea99ee380514…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-487-302020-01-31C16284748780-19d75b9d0-a7ef-f424-e053-dadaa90a57ceINDOMETHACIN
61919-487-602020-01-31C16284748780-19d75b9d0-a7ef-f424-e053-dadaa90a57ceINDOMETHACIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-487-30INDOMETHACIN30 in 1 BOTTLECAPSULE301
61919-487-60INDOMETHACIN60 in 1 BOTTLECAPSULE601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE [DIRECTRX]1
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE [DIRECTRX]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHINDOMETHACIN CAPSULE [DIRECTRX]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE [DIRECTRX]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYINDOMETHACIN CAPSULE [DIRECTRX]1
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE [DIRECTRX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INDOMETHACIN CAPSULE [DIRECTRX]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EINDOMETHACIN CAPSULE [DIRECTRX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN CAPSULE [DIRECTRX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE [DIRECTRX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJINDOMETHACIN CAPSULE [DIRECTRX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-487INDOMETHACIN CAPSULE [DIRECTRX]1Legacy NDC, 2 package rows20151022_74099022-892a-46d8-a64e-4a9d7d3256cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197818indomethacin 50 MG Oral CapsulePSN74099022-892a-46d8-a64e-4a9d7d3256cd1
197818indomethacin 50 MG Oral CapsuleSCD74099022-892a-46d8-a64e-4a9d7d3256cd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-487-306191904873030 in 1 BOTTLEHistorical
61919-487-606191904876060 in 1 BOTTLEHistorical