Home NDC 62135-067 INDOMETHACIN
Product NDC 62135-067
11-digit product format 621350067
Labeler code 62135
Product ID 62135-067_3143c8a1-9d17-9eb6-e063-6394a90ab16b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name INDOMETHACIN
Dosage form CAPSULE
Route ORAL
Labeler Chartwell RX, LLC
Application NDA018829
Marketing category NDA AUTHORIZED GENERIC
Marketing start 1984-08-06
Substance INDOMETHACIN
Active strength 25 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 42 .
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 N018829-001 INDOMETHACIN INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 N018829-002 INDOMETHACIN INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 84 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 2026-08-18 06:07:40 2026-07 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL AB 1984-08-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL AB 1984-08-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL 1984-08-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL 1984-08-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL 1984-08-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL 1984-08-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL 1984-08-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL 1984-08-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL 1984-08-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL 1984-08-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018829-001 INDOMETHACIN 50MG CAPSULE / ORAL 1984-08-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N018829-002 INDOMETHACIN 25MG CAPSULE / ORAL 1984-08-06 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
Additional Listing Data#
Finished product Yes
Brand name base INDOMETHACIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength INDOMETHACIN 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination XXE1CET956 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197817 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62135-067-18 INDOMETHACIN 180 in 1 BOTTLE CAPSULE 180 4 62135-067-90 INDOMETHACIN 90 in 1 BOTTLE CAPSULE 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-067 INDOMETHACIN CAPSULE [CHARTWELL RX, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20250328_9607920c-4d25-40b9-957e-87e9ca5574e8.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 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 62135-067-18 62135006718 180 CAPSULE in 1 BOTTLE (62135-067-18) 180 capsule 2022-09-30 0000-00-00 No No Current 62135-067-90 62135006790 90 CAPSULE in 1 BOTTLE (62135-067-90) 90 capsule 2022-09-30 0000-00-00 No No Current