Home NDC 63629-1780 Indomethacin
Product NDC 63629-1780
11-digit product format 636291780
Labeler code 63629
Product ID 63629-1780_a6c208ad-9330-46c8-a65b-2e6f8db845de
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Indomethacin
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application NDA018851
Marketing category NDA
Marketing start 2010-07-10
Marketing end 0000-00-00
Substance INDOMETHACIN
Active strength 25 mg/1
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 78 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018851-001 INDOMETHACIN INDOMETHACIN 25MG CAPSULE / ORAL 1984-05-18 N018851-002 INDOMETHACIN INDOMETHACIN 50MG CAPSULE / ORAL 1984-05-18
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 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N018851-001 INDOMETHACIN 25MG CAPSULE / ORAL 1984-05-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018851-002 INDOMETHACIN 50MG CAPSULE / ORAL 1984-05-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N018851-001 INDOMETHACIN 25MG CAPSULE / ORAL 1984-05-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018851-002 INDOMETHACIN 50MG CAPSULE / ORAL 1984-05-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018851-001 INDOMETHACIN 25MG CAPSULE / ORAL 1984-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018851-002 INDOMETHACIN 50MG CAPSULE / ORAL 1984-05-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018851-001 INDOMETHACIN 25MG CAPSULE / ORAL 1984-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018851-002 INDOMETHACIN 50MG CAPSULE / ORAL 1984-05-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018851-001 INDOMETHACIN 25MG CAPSULE / ORAL 1984-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018851-002 INDOMETHACIN 50MG CAPSULE / ORAL 1984-05-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018851-001 INDOMETHACIN 25MG CAPSULE / ORAL 1984-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018851-002 INDOMETHACIN 50MG CAPSULE / ORAL 1984-05-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018851-001 INDOMETHACIN 25MG CAPSULE / ORAL 1984-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018851-002 INDOMETHACIN 50MG CAPSULE / ORAL 1984-05-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018851-001 INDOMETHACIN 25MG CAPSULE / ORAL 1984-05-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018851-002 INDOMETHACIN 50MG CAPSULE / ORAL 1984-05-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018851-001 INDOMETHACIN 25MG CAPSULE / ORAL 1984-05-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018851-002 INDOMETHACIN 50MG CAPSULE / ORAL 1984-05-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018851-001 INDOMETHACIN 25MG CAPSULE / ORAL 1984-05-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018851-002 INDOMETHACIN 50MG CAPSULE / ORAL 1984-05-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018851-001 INDOMETHACIN 25MG CAPSULE / ORAL 1984-05-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018851-002 INDOMETHACIN 50MG CAPSULE / ORAL 1984-05-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018851-001 INDOMETHACIN 25MG CAPSULE / ORAL 1984-05-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018851-002 INDOMETHACIN 50MG CAPSULE / ORAL 1984-05-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018851-001 INDOMETHACIN 25MG CAPSULE / ORAL 1984-05-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018851-002 INDOMETHACIN 50MG CAPSULE / ORAL 1984-05-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018851-001 INDOMETHACIN 25MG CAPSULE / ORAL 1984-05-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018851-002 INDOMETHACIN 50MG CAPSULE / ORAL 1984-05-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018851-001 INDOMETHACIN 25MG CAPSULE / ORAL 1984-05-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018851-002 INDOMETHACIN 50MG CAPSULE / ORAL 1984-05-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018851-001 INDOMETHACIN 25MG CAPSULE / ORAL 1984-05-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N018851-002 INDOMETHACIN 50MG CAPSULE / ORAL 1984-05-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018851-001 INDOMETHACIN 25MG CAPSULE / ORAL 1984-05-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018851-002 INDOMETHACIN 50MG CAPSULE / ORAL 1984-05-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018851-001 INDOMETHACIN 25MG CAPSULE / ORAL 1984-05-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N018851-002 INDOMETHACIN 50MG CAPSULE / ORAL 1984-05-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018851-001 INDOMETHACIN 25MG CAPSULE / ORAL 1984-05-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N018851-002 INDOMETHACIN 50MG CAPSULE / ORAL 1984-05-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018851-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-05-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N018851-002 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-05-18 74a2ff9319b5…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 63629-1780-1 2020-10-16 Indomethacin PAS These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. Indomethacin Capsules, USP, for oral use Initial U.S. Approval: 1965 63629-1780-2 2020-10-16 Indomethacin PAS These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. Indomethacin Capsules, USP, for oral use Initial U.S. Approval: 1965 63629-1780-3 2020-10-16 Indomethacin PAS These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. Indomethacin Capsules, USP, for oral use Initial U.S. Approval: 1965 63629-1780-4 2020-10-16 Indomethacin PAS These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. Indomethacin Capsules, USP, for oral use Initial U.S. Approval: 1965 63629-1780-5 2020-10-16 Indomethacin PAS These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. Indomethacin Capsules, USP, for oral use Initial U.S. Approval: 1965 63629-1780-1 2020-01-31 Indomethacin PAS These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. Indomethacin Capsules, USP, for oral use Initial U.S. Approval: 1965 63629-1780-2 2020-01-31 Indomethacin PAS These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. Indomethacin Capsules, USP, for oral use Initial U.S. Approval: 1965 63629-1780-3 2020-01-31 Indomethacin PAS These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. Indomethacin Capsules, USP, for oral use Initial U.S. Approval: 1965 63629-1780-4 2020-01-31 Indomethacin PAS These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. Indomethacin Capsules, USP, for oral use Initial U.S. Approval: 1965 63629-1780-5 2020-01-31 Indomethacin PAS These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. Indomethacin Capsules, USP, for oral use Initial U.S. Approval: 1965
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-1780-1 63629178001 20 CAPSULE in 1 BOTTLE (63629-1780-1) 20 capsule 2011-02-21 0000-00-00 No No Current 63629-1780-2 63629178002 30 CAPSULE in 1 BOTTLE (63629-1780-2) 30 capsule 2011-02-21 0000-00-00 No No Current 63629-1780-3 63629178003 60 CAPSULE in 1 BOTTLE (63629-1780-3) 60 capsule 2011-02-21 0000-00-00 No No Current 63629-1780-4 63629178004 90 CAPSULE in 1 BOTTLE (63629-1780-4) 90 capsule 2011-02-21 0000-00-00 No No Current 63629-1780-5 63629178005 21 CAPSULE in 1 BOTTLE (63629-1780-5) 21 capsule 2011-02-21 0000-00-00 No No Current