INDOMETHACIN

Product NDC
61919-164
11-digit product format
619190164
Labeler code
61919
Product ID
61919-164_151f8422-70b3-cf70-e063-6294a90a90fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
INDOMETHACIN
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA091276
Marketing category
ANDA
Marketing start
2017-04-20
Substance
INDOMETHACIN
Active strength
50 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
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
INDOMETHACIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INDOMETHACIN50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
XXE1CET956Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197817Internal RxNorm lookup
197818Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4d9a253a-f014-4fab-e054-00144ff8d46cAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-164-21INDOMETHACIN21 in 1 BOTTLECAPSULE217
61919-164-30INDOMETHACIN30 in 1 BOTTLECAPSULE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-164-21EA - Each61919-16439339ebd-a1b7-413f-8a9c-01d24032b1c312019-11-12
61919-164-30EA - Each61919-16465632238-8946-4bd1-ae97-0407998ba65912017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-164INDOMETHACIN CAPSULE [DIRECT RX]7Current NDC, Legacy NDC, 2 package rows20240403_4d9a253a-f014-4fab-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
ndc (product): 61919-164
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 CapsulePSN4d9a253a-f014-4fab-e054-00144ff8d46c7
197818indomethacin 50 MG Oral CapsulePSN4d9a253a-f014-4fab-e054-00144ff8d46c7
197817indomethacin 25 MG Oral CapsuleSCD4d9a253a-f014-4fab-e054-00144ff8d46c7
197818indomethacin 50 MG Oral CapsuleSCD4d9a253a-f014-4fab-e054-00144ff8d46c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-164-216191901642121 CAPSULE in 1 BOTTLE (61919-164-21) 21 capsule2017-04-200000-00-00NoNoCurrent
61919-164-306191901643030 CAPSULE in 1 BOTTLE (61919-164-30) 30 capsule2017-04-200000-00-00NoNoCurrent