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#

Productindomethacin
Active ingredientINDOMETHACIN
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1004-01

Indomethacin capsules USP, 25 mg

100 Capsules

Rx only

Indomethacin Capsules, USP
Indomethacin Capsules, USP

NDC 70771-1005-01

Indomethacin capsules USP, 50 mg

100 Capsules

Rx only

IndomethacineCapsules, USP
IndomethacineCapsules, USP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1004INDOMETHACIN CAPSULE [ZYDUS LIFESCIENCES LIMITED]6Legacy NDC20240821_129eaf3a-b013-4b29-a58f-1565f9f41d5b.zip
70771-1005INDOMETHACIN CAPSULE [ZYDUS LIFESCIENCES LIMITED]6Legacy NDC20240821_129eaf3a-b013-4b29-a58f-1565f9f41d5b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A090403-001INDOMETHACININDOMETHACIN25MGCAPSULE / ORALAB2010-11-15
A090403-002INDOMETHACININDOMETHACIN50MGCAPSULE / ORALAB2010-11-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090403-001AB
A090403-002AB

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-15c2088c7a36db…
2026-10-15 13:18:302026-09A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-15c2088c7a36db…
2026-09-14 22:38:342026-08A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-1584e616aacf4f…
2026-09-14 22:38:342026-08A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-1584e616aacf4f…
2026-08-18 06:07:402026-07A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-15caaa826d4ba7…
2026-08-18 06:07:402026-07A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090403-001INDOMETHACIN25MGCAPSULE / ORALAB2010-11-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090403-002INDOMETHACIN50MGCAPSULE / ORALAB2010-11-154b0b4de00fa7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A090403-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A090403-002AB1c2088c7a36db…
2026-09-14 22:38:342026-08A090403-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090403-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A090403-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090403-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090403-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090403-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090403-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090403-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090403-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090403-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090403-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090403-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090403-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090403-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090403-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090403-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090403-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090403-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090403-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090403-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090403-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090403-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090403-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090403-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090403-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090403-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090403-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090403-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090403-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090403-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090403-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090403-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090403-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090403-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090403-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090403-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090403-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090403-002AB14b0b4de00fa7…

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e49f4c7d-821f-46d6-bb1c-06c4235f55ce129eaf3a-b013-4b29-a58f-1565f9f41d5b2025-08-14Exact identifier
spl set id: 129eaf3a-b013-4b29-a58f-1565f9f41d5b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.