Indomethacin

Product NDC
63629-8994
Requested package NDC
63629-8994-2
11-digit product format
636298994
Labeler code
63629
Product ID
63629-8994_3b5a34fe-e05d-4320-ade2-61ea1e73a840
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091240
Marketing category
ANDA
Marketing start
2016-05-19
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
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…

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
3fd56b7d-2799-4211-9a58-c6c1dc8c70dcAvailable 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
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
63629-8994-1Indomethacin30 in 1 BOTTLECAPSULE30102
63629-8994-2Indomethacin60 in 1 BOTTLECAPSULE60102
63629-8994-3Indomethacin90 in 1 BOTTLECAPSULE90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8994-1EA - Each63629-899481641be3-9f9e-402b-aafd-02bd59c34e7012022-03-09
63629-8994-2EA - Each63629-8994447a0a54-f900-4990-9bc2-28a3dc1ffd2912022-03-09
63629-8994-3EA - Each63629-89948853308b-ddb8-4b5d-a05b-887ff0772ac612022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8994INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 3 package rows20250330_3fd56b7d-2799-4211-9a58-c6c1dc8c70dc.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 · 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
ndc (package): 63629-8994-2
ndc (product): 63629-8994
ndc11 (package): 63629899402
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197818indomethacin 50 MG Oral CapsulePSN3fd56b7d-2799-4211-9a58-c6c1dc8c70dc102
197818indomethacin 50 MG Oral CapsuleSCD3fd56b7d-2799-4211-9a58-c6c1dc8c70dc102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8994-26362989940260 CAPSULE in 1 BOTTLE (63629-8994-2) 60 capsule2021-12-070000-00-00NoNoCurrent