Indomethacin
- Product NDC
- 65162-506
- 11-digit product format
- 651620506
- Labeler code
- 65162
- Product ID
- 65162-506_083ef389-551a-48c5-9a92-f16fb6270ae4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA091549
- Marketing category
- ANDA
- Marketing start
- 2010-12-06
- Substance
- INDOMETHACIN
- Active strength
- 75 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091549-001 | INDOMETHACIN | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091549-001 | AB |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A091549-001 | INDOMETHACIN | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2010-12-01 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A091549-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A091549-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091549-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091549-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091549-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091549-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091549-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091549-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091549-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091549-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091549-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091549-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091549-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091549-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091549-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091549-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A091549-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A091549-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A091549-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A091549-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A091549-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091549-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A091549-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A091549-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A091549-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A091549-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A091549-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A091549-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091549-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A091549-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A091549-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091549-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091549-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091549-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091549-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A091549-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A091549-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091549-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A091549-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A091549-001 | AB | 1 | e64feba35796… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Indomethacin
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| INDOMETHACIN | 75 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| XXE1CET956 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 310992 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| dbad7e61-2347-43b1-a422-9183e41c10ea | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 234b5275-84d6-d169-e08f-554a8aed3f0a | Product name | 3 | 20250717 |
| 9aaf7cf4-60c3-b44f-e302-fd8b276c713b | Product name | 2 | 20250107 |
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| c6b2f0e9-1a13-02e4-f789-55c724469f07 | Product name | 7 | 20171115 |
| 6e9718b9-62b9-458f-9408-30d688800922 | Product name | 1 | 20171103 |
| d62774ab-b1b9-2d5c-924f-1948e411ae15 | Product name | 3 | 20170816 |
| 97c70338-ee37-4c78-a047-53ee1cd9b53d | Product name | 1 | 20150616 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65162-506-03 | Indomethacin | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | 29 | |
| 65162-506-06 | Indomethacin | 60 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 60 | 29 | |
| 65162-506-09 | Indomethacin | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | 29 | |
| 65162-506-10 | Indomethacin | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | 29 | |
| 65162-506-11 | Indomethacin | 1000 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 1000 | 29 | |
| 65162-506-50 | Indomethacin | 500 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 500 | 29 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65162-506-03 | EA - Each | 65162-506 | 2bb06218-8eab-4ea3-babc-3acff841a3e1 | 1 | 2012-07-24 |
| 65162-506-06 | EA - Each | 65162-506 | 81b8c104-e113-4e70-b9ca-daf14bedcaf4 | 1 | 2012-07-24 |
| 65162-506-09 | EA - Each | 65162-506 | 85deac06-5486-48fd-8569-87f30735ac86 | 1 | 2012-07-24 |
| 65162-506-50 | EA - Each | 65162-506 | 1b93f822-6738-4ea2-947a-565fbf88218d | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Indomethacin | INDOMETHACIN | Amneal Pharmaceuticals LLC | dbad7e61-2347-43b1-a422-9183e41c10ea | 2024-07-15 | Boxed warning, Warnings, Adverse reactions | 091549 ANDA091549 65162-506 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310992 | indomethacin 75 MG Extended Release Oral Capsule | PSN | dbad7e61-2347-43b1-a422-9183e41c10ea | 29 |
| 310992 | indomethacin 75 MG Extended Release Oral Capsule | SCD | dbad7e61-2347-43b1-a422-9183e41c10ea | 29 |
| 310992 | indomethacin 75 MG Extended Release Oral Capsule | PSN | 17c9214f-0eba-0088-e054-00144ff88e88 | 5 |
| 310992 | indomethacin 75 MG Extended Release Oral Capsule | SCD | 17c9214f-0eba-0088-e054-00144ff88e88 | 5 |
| 310992 | indomethacin 75 MG Extended Release Oral Capsule | PSN | 29a6b41c-accb-4b12-92d1-cda19c2148a5 | 1 |
| 310992 | indomethacin 75 MG Extended Release Oral Capsule | SCD | 29a6b41c-accb-4b12-92d1-cda19c2148a5 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 65162-506-03 | 65162050603 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-03) | 2010-12-06 | 0000-00-00 | No | No | Current |
| 65162-506-06 | 65162050606 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-06) | 2010-12-06 | 0000-00-00 | No | No | Current |
| 65162-506-09 | 65162050609 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-09) | 2010-12-06 | 0000-00-00 | No | No | Current |
| 65162-506-10 | 65162050610 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-10) | 2010-12-06 | 0000-00-00 | No | No | Current |
| 65162-506-11 | 65162050611 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-11) | 2010-12-06 | 0000-00-00 | No | No | Current |
| 65162-506-50 | 65162050650 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-50) | 2010-12-06 | 0000-00-00 | No | No | Current |