Indomethacin

Product NDC
43063-883
11-digit product format
430630883
Labeler code
43063
Product ID
43063-883_7394530b-b290-550c-e053-2991aa0a0711
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA091240
Marketing category
ANDA
Marketing start
2011-11-01
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
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43063-883DDiscontinued by firm2026-08-03
excluded packagepackage43063-88343063-883-20DDiscontinued 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 · 24 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 packagepackage43063-883-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-883-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-883-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-883-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-883-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-883-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43063-883-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43063-883-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43063-883-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43063-883-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43063-883-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43063-883-20557ba5c1ecfa…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
A091240-001INDOMETHACININDOMETHACIN25MGCAPSULE / ORALAB2011-04-12
A091240-002INDOMETHACININDOMETHACIN50MGCAPSULE / ORALAB2011-04-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091240-001AB
A091240-002AB

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 UTC2026-02A091240-001INDOMETHACIN25MGCAPSULE / ORALAB2011-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091240-002INDOMETHACIN50MGCAPSULE / ORALAB2011-04-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091240-001INDOMETHACIN25MGCAPSULE / ORALAB2011-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091240-002INDOMETHACIN50MGCAPSULE / ORALAB2011-04-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A091240-001INDOMETHACIN25MGCAPSULE / ORALAB2011-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091240-002INDOMETHACIN50MGCAPSULE / ORALAB2011-04-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091240-001INDOMETHACIN25MGCAPSULE / ORALAB2011-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091240-002INDOMETHACIN50MGCAPSULE / ORALAB2011-04-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091240-001INDOMETHACIN25MGCAPSULE / ORALAB2011-04-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091240-002INDOMETHACIN50MGCAPSULE / ORALAB2011-04-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091240-001INDOMETHACIN25MGCAPSULE / ORALAB2011-04-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091240-002INDOMETHACIN50MGCAPSULE / ORALAB2011-04-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091240-001INDOMETHACIN25MGCAPSULE / ORALAB2011-04-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091240-002INDOMETHACIN50MGCAPSULE / ORALAB2011-04-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091240-001INDOMETHACIN25MGCAPSULE / ORALAB2011-04-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091240-002INDOMETHACIN50MGCAPSULE / ORALAB2011-04-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091240-001INDOMETHACIN25MGCAPSULE / ORALAB2011-04-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091240-002INDOMETHACIN50MGCAPSULE / ORALAB2011-04-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091240-001INDOMETHACIN25MGCAPSULE / ORALAB2011-04-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A091240-002INDOMETHACIN50MGCAPSULE / ORALAB2011-04-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091240-001INDOMETHACIN25MGCAPSULE / ORALAB2011-04-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091240-002INDOMETHACIN50MGCAPSULE / ORALAB2011-04-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091240-001INDOMETHACIN25MGCAPSULE / ORALAB2011-04-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091240-002INDOMETHACIN50MGCAPSULE / ORALAB2011-04-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091240-001INDOMETHACIN25MGCAPSULE / ORALAB2011-04-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091240-002INDOMETHACIN50MGCAPSULE / ORALAB2011-04-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091240-001INDOMETHACIN25MGCAPSULE / ORALAB2011-04-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091240-002INDOMETHACIN50MGCAPSULE / ORALAB2011-04-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091240-001INDOMETHACIN25MGCAPSULE / ORALAB2011-04-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091240-002INDOMETHACIN50MGCAPSULE / ORALAB2011-04-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091240-001INDOMETHACIN25MGCAPSULE / ORALAB2011-04-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091240-002INDOMETHACIN50MGCAPSULE / ORALAB2011-04-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091240-001INDOMETHACIN25MGCAPSULE / ORALAB2011-04-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091240-002INDOMETHACIN50MGCAPSULE / ORALAB2011-04-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091240-001INDOMETHACIN25MGCAPSULE / ORALAB2011-04-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091240-002INDOMETHACIN50MGCAPSULE / ORALAB2011-04-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091240-001INDOMETHACIN25MGCAPSULE / ORALAB2011-04-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091240-002INDOMETHACIN50MGCAPSULE / ORALAB2011-04-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091240-001INDOMETHACIN25MGCAPSULE / ORALAB2011-04-12782e0a99824c…
2021-12-28 21:50 UTC2021-12A091240-002INDOMETHACIN50MGCAPSULE / ORALAB2011-04-12782e0a99824c…

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 UTC2026-02A091240-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091240-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091240-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091240-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091240-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091240-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091240-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091240-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091240-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091240-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091240-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091240-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091240-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091240-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091240-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091240-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091240-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091240-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091240-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091240-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091240-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091240-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091240-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091240-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091240-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091240-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091240-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091240-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091240-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091240-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091240-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091240-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091240-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091240-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091240-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091240-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091240-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091240-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091240-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091240-002AB1782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-883-20EA - Each43063-8830675e7d7-18dd-4cc9-83ba-0df27e5dab2612018-09-05

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IndomethacinINDOMETHACINSt. Mary's Medical Park Pharmacy205fc4e7-e118-509e-e063-6394a90a78e62026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINPD-Rx Pharmaceuticals, Inc.ce866d3a-7bea-4d82-9b7d-79e8a294c1412026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINPD-Rx Pharmaceuticals, Inc.d66ada00-3ece-4b71-8c59-a0db48a2db802026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINA-S Medication Solutionsd2997707-1541-4f5d-8c8d-70b0a13be8b22026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINPreferred Pharmaceuticals, Inc.3785c914-0037-49ef-b6f5-a5e868ae490b2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
INDOMETHACININDOMETHACINDIRECT RX7e7175d7-5e43-4151-9702-88ac2cd44ef62026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINNorthwind Health Company, LLCdffe9b95-3cb6-4c4e-e053-2a95a90a93282026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINPreferred Pharmaceuticals Inc.971c4d53-7876-4f42-ba2d-c391714fa3412025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINA-S Medication Solutions5b05b8bc-4df0-4175-bf53-72129fb21b502025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINBryant Ranch Prepacka329976b-4a01-42ea-a666-0ac99ed2522e2025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINCamber Pharmaceuticals, Inc.1ce9c3c5-0cf7-4760-988d-2559adcfb2002025-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINBryant Ranch Prepack4cc7ef3b-fddd-49dd-85d1-cbb3d5c17ff72025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINBryant Ranch Prepack67b16cf2-e24c-4fe3-8d74-e63549b7659f2025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINBryant Ranch Prepackb1bb9349-21e4-4e6a-9916-3aac6c4d01b82025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINBryant Ranch Prepack3fd56b7d-2799-4211-9a58-c6c1dc8c70dc2025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINBryant Ranch Prepack2f4a5796-5317-4caa-83e4-0595fe844df42025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINAvPAKbcaa0e51-a2fc-cf74-027a-1964e38c5e4e2025-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINBryant Ranch Prepack9236d783-d7b8-4486-94c6-5ecd876bc4752024-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINBryant Ranch Prepack56e19868-3973-4f1b-b80f-1f7daf1f1c222024-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240
IndomethacinINDOMETHACINBryant Ranch Prepackafbb24fd-3695-4a30-a8a6-36239e35a14f2024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091240
application number: ANDA091240