Home NDC 68788-6983 Indomethacin
Product NDC 68788-6983
11-digit product format 687886983
Labeler code 68788
Product ID 68788-6983_ca097033-3266-48c7-8a73-ee2fa1f78d4b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Indomethacin
Dosage form CAPSULE
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA091276
Marketing category ANDA
Marketing start 2017-07-05
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
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-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 · 88 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 2026-10-15 13:18:30 2026-09 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 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 68788-6983 INDOMETHACIN CAPSULE [PREFERRED PHARMACEUTICALS INC.] 7 Legacy NDC 20240321_ae5c0754-71eb-42ac-b3ab-e16fe61949b5.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 68788-6983-2 68788698302 20 CAPSULE in 1 BOTTLE (68788-6983-2) 20 capsule 2017-07-05 0000-00-00 No No Current 68788-6983-3 68788698303 30 CAPSULE in 1 BOTTLE (68788-6983-3) 30 capsule 2017-07-05 0000-00-00 No No Current