Indomethacin

Product NDC
67296-0723
Requested package NDC
67296-0723-3
11-digit product format
672960723
Labeler code
67296
Product ID
67296-0723_d5fc2e9d-59db-29cd-e053-2a95a90afa52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA091276
Marketing category
ANDA
Marketing start
2010-12-22
Marketing end
0000-00-00
Substance
INDOMETHACIN
Active strength
25 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67296-072367296-0723-3IInactivated 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 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A091276-001INDOMETHACININDOMETHACIN25MGCAPSULE / ORALAB2010-12-22
A091276-002INDOMETHACININDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091276-001AB
A091276-002AB

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 UTC2026-02A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091276-001INDOMETHACIN25MGCAPSULE / ORALAB2010-12-22782e0a99824c…
2021-12-28 21:50 UTC2021-12A091276-002INDOMETHACIN50MGCAPSULE / ORALABRS2010-12-22782e0a99824c…

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 UTC2026-02A091276-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091276-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091276-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091276-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091276-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091276-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091276-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091276-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091276-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091276-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091276-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091276-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091276-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091276-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091276-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091276-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091276-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091276-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091276-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091276-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091276-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091276-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091276-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091276-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091276-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091276-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091276-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091276-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091276-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091276-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091276-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091276-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091276-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091276-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091276-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091276-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091276-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091276-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091276-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091276-002AB1782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
234b5275-84d6-d169-e08f-554a8aed3f0aProduct name320250717
9aaf7cf4-60c3-b44f-e302-fd8b276c713bProduct name220250107
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
67296-0723-1Indomethacin15 in 1 BOTTLECAPSULE157
67296-0723-2Indomethacin30 in 1 BOTTLECAPSULE307
67296-0723-3Indomethacin10 in 1 BOTTLECAPSULE107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0723INDOMETHACIN CAPSULE [REDPHARM DRUG, INC.]7Legacy NDC, 3 package rows20241004_4172e7ee-58e1-5aef-e054-00144ff8d46c.zip

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 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IndomethacinINDOMETHACINREMEDYREPACK INC.bf93022c-a965-49c5-a852-c59e580d7d912026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINPD-Rx Pharmaceuticals, Inc.009097a5-2c1e-4f5d-8054-896cf896cb3d2026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINPD-Rx Pharmaceuticals, Inc.99d7a84b-c755-47be-9d2d-1223162b0a422026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINBryant Ranch Prepackbf11f5a0-f2ee-499a-8d54-9d557cc668412026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINPreferred Pharmaceuticals Inc.1bb80a9f-def3-4228-ab04-a0c2a117a2b92026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINCoupler LLC51266787-b50e-bc15-e063-6394a90ad16f2026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINSt. Mary's Medical Park Pharmacy6312c9a6-d4d3-eb1f-e053-2991aa0a5e682026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINPD-Rx Pharmaceuticals, Inc.b4cf01d1-0d71-4f0f-97a5-07a59744149f2026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINREMEDYREPACK INC.16238287-d4b0-4afa-8483-1f4ae250a6252026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINRedPharm Drug, Inc.4d9ef14a-4812-4fcf-e054-00144ff8d46c2026-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINA-S Medication Solutions7755391e-ede3-4a32-854c-736dc6dd2ee32026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINA-S Medication Solutions927af761-2f37-4e81-a86e-d4fb17cc18972026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINNorthwind Health Company, LLCc9f4eda2-5c8f-72eb-e053-2a95a90a06be2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINNorthwind Health Company, LLCdb0f1127-ebd8-636c-e053-2a95a90a4d442026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINGlenmark Pharmaceuticals Inc., USAf7ed39e2-5431-4e47-935c-c7441d058f942025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINA-S Medication Solutions175a2d81-0d0f-46a3-aaaa-1732982d85fd2024-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINBryant Ranch Prepack9ce37860-407f-47c7-a64c-62b6cc7292982024-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINNuCare Pharmaceuticals, Inc.503455d9-471e-554f-e054-00144ff88e882024-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
INDOMETHACININDOMETHACINDIRECT RX4d9a253a-f014-4fab-e054-00144ff8d46c2024-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276
IndomethacinINDOMETHACINProficient Rx LP86c94559-b453-4e61-a76c-6962872f06552022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091276
application number: ANDA091276

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197817indomethacin 25 MG Oral CapsulePSN4172e7ee-58e1-5aef-e054-00144ff8d46c7
197817indomethacin 25 MG Oral CapsuleSCD4172e7ee-58e1-5aef-e054-00144ff8d46c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-0723-36729607230310 CAPSULE in 1 BOTTLE (67296-0723-3) 10 capsule2010-12-220000-00-00NoNoCurrent