INDOMETHACIN CAPSULES
- Manufacturer
- Zydus Lifesciences Limited
- Effective date
- 2024-08-16
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:56:20
Label at a glance#
Label contents#
Full prescribing information#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70771-1004 | INDOMETHACIN CAPSULE [ZYDUS LIFESCIENCES LIMITED] | 6 | Legacy NDC | 20240821_129eaf3a-b013-4b29-a58f-1565f9f41d5b.zip |
| 70771-1005 | INDOMETHACIN CAPSULE [ZYDUS LIFESCIENCES LIMITED] | 6 | Legacy NDC | 20240821_129eaf3a-b013-4b29-a58f-1565f9f41d5b.zip |
Products#
Every source-derived product name is available through these pages.
- indomethacin
- FERROSOFERRIC OXIDE
- SILICON DIOXIDE
- GELATIN
- FD&C BLUE NO. 1
- FD&C YELLOW NO. 5
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- POWDERED CELLULOSE
- SODIUM LAURYL SULFATE
- SODIUM STARCH GLYCOLATE TYPE A CORN
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70771-1004 | 70771-1004-1, 70771-1004-5, 70771-1004-0, 70771-1004-2 |
| 70771-1005 | 70771-1005-1, 70771-1005-5, 70771-1005-0, 70771-1005-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090403-001 | INDOMETHACIN | INDOMETHACIN | 25MG | CAPSULE / ORAL | AB | 2010-11-15 | |
| A090403-002 | INDOMETHACIN | INDOMETHACIN | 50MG | CAPSULE / ORAL | AB | 2010-11-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090403-001 | AB |
| A090403-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A090403-001 | INDOMETHACIN | 25MG | CAPSULE / ORAL | AB | 2010-11-15 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A090403-002 | INDOMETHACIN | 50MG | CAPSULE / ORAL | AB | 2010-11-15 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A090403-001 | INDOMETHACIN | 25MG | CAPSULE / ORAL | AB | 2010-11-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090403-002 | INDOMETHACIN | 50MG | CAPSULE / ORAL | AB | 2010-11-15 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A090403-001 | INDOMETHACIN | 25MG | CAPSULE / ORAL | AB | 2010-11-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090403-002 | INDOMETHACIN | 50MG | CAPSULE / ORAL | AB | 2010-11-15 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090403-001 | INDOMETHACIN | 25MG | CAPSULE / ORAL | AB | 2010-11-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090403-002 | INDOMETHACIN | 50MG | CAPSULE / ORAL | AB | 2010-11-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090403-001 | INDOMETHACIN | 25MG | CAPSULE / ORAL | AB | 2010-11-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090403-002 | INDOMETHACIN | 50MG | CAPSULE / ORAL | AB | 2010-11-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090403-001 | INDOMETHACIN | 25MG | CAPSULE / ORAL | AB | 2010-11-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090403-002 | INDOMETHACIN | 50MG | CAPSULE / ORAL | AB | 2010-11-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090403-001 | INDOMETHACIN | 25MG | CAPSULE / ORAL | AB | 2010-11-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090403-002 | INDOMETHACIN | 50MG | CAPSULE / ORAL | AB | 2010-11-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090403-001 | INDOMETHACIN | 25MG | CAPSULE / ORAL | AB | 2010-11-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090403-002 | INDOMETHACIN | 50MG | CAPSULE / ORAL | AB | 2010-11-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090403-001 | INDOMETHACIN | 25MG | CAPSULE / ORAL | AB | 2010-11-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090403-002 | INDOMETHACIN | 50MG | CAPSULE / ORAL | AB | 2010-11-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090403-001 | INDOMETHACIN | 25MG | CAPSULE / ORAL | AB | 2010-11-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090403-002 | INDOMETHACIN | 50MG | CAPSULE / ORAL | AB | 2010-11-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090403-001 | INDOMETHACIN | 25MG | CAPSULE / ORAL | AB | 2010-11-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090403-002 | INDOMETHACIN | 50MG | CAPSULE / ORAL | AB | 2010-11-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090403-001 | INDOMETHACIN | 25MG | CAPSULE / ORAL | AB | 2010-11-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090403-002 | INDOMETHACIN | 50MG | CAPSULE / ORAL | AB | 2010-11-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090403-001 | INDOMETHACIN | 25MG | CAPSULE / ORAL | AB | 2010-11-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090403-002 | INDOMETHACIN | 50MG | CAPSULE / ORAL | AB | 2010-11-15 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090403-001 | INDOMETHACIN | 25MG | CAPSULE / ORAL | AB | 2010-11-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090403-002 | INDOMETHACIN | 50MG | CAPSULE / ORAL | AB | 2010-11-15 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090403-001 | INDOMETHACIN | 25MG | CAPSULE / ORAL | AB | 2010-11-15 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090403-002 | INDOMETHACIN | 50MG | CAPSULE / ORAL | AB | 2010-11-15 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090403-001 | INDOMETHACIN | 25MG | CAPSULE / ORAL | AB | 2010-11-15 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090403-002 | INDOMETHACIN | 50MG | CAPSULE / ORAL | AB | 2010-11-15 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090403-001 | INDOMETHACIN | 25MG | CAPSULE / ORAL | AB | 2010-11-15 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090403-002 | INDOMETHACIN | 50MG | CAPSULE / ORAL | AB | 2010-11-15 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090403-001 | INDOMETHACIN | 25MG | CAPSULE / ORAL | AB | 2010-11-15 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090403-002 | INDOMETHACIN | 50MG | CAPSULE / ORAL | AB | 2010-11-15 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090403-001 | INDOMETHACIN | 25MG | CAPSULE / ORAL | AB | 2010-11-15 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090403-002 | INDOMETHACIN | 50MG | CAPSULE / ORAL | AB | 2010-11-15 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090403-001 | INDOMETHACIN | 25MG | CAPSULE / ORAL | AB | 2010-11-15 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090403-002 | INDOMETHACIN | 50MG | CAPSULE / ORAL | AB | 2010-11-15 | 4b0b4de00fa7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A090403-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A090403-002 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A090403-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090403-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090403-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090403-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090403-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090403-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090403-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090403-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090403-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090403-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090403-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090403-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090403-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090403-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090403-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090403-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090403-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090403-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090403-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090403-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090403-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090403-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090403-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090403-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090403-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090403-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090403-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090403-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090403-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090403-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090403-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A090403-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090403-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090403-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090403-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090403-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090403-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090403-002 | AB | 1 | 4b0b4de00fa7… |
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 |
|---|---|---|---|---|---|---|
| e49f4c7d-821f-46d6-bb1c-06c4235f55ce | 129eaf3a-b013-4b29-a58f-1565f9f41d5b | 2025-08-14 | 129eaf3a-b013-4b29-a58f-1565f9f41d5b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

