Home NDC 70518-0254 Indomethacin
Product NDC 70518-0254
11-digit product format 705180254
Labeler code 70518
Product ID 70518-0254_ed0b57cd-4cfb-29d0-e053-2995a90a3cb1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Indomethacin
Dosage form CAPSULE
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA091276
Marketing category ANDA
Marketing start 2017-02-23
Marketing end 0000-00-00
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 2023-12-31
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 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70518-0254-0 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70518-0254-0 f5e01cc5f278…a2eaf40c39c3…
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 A091276-001 INDOMETHACIN INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 A091276-002 INDOMETHACIN INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22
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 · 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 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-0254 INDOMETHACIN CAPSULE [REMEDYREPACK INC.] 14 Legacy NDC 20250425_d5f523fe-96eb-4f92-bf32-0c5d7eaf4d8e.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 2 of 2 · 21 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70518-0254-0 70518025400 30 CAPSULE in 1 BLISTER PACK (70518-0254-0) 30 capsule 2017-02-23 0000-00-00 No No Current