Home NDC 23155-010 Indomethacin
Product NDC 23155-010
11-digit product format 231550010
Labeler code 23155
Product ID 23155-010_50cc267d-ae19-4877-8729-97d754e5a497
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Indomethacin
Dosage form CAPSULE
Route ORAL
Labeler Heritage Pharmaceuticals Inc.
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 2020-12-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 82 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 2026-02-19 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…2022-03-09 01:35 UTC 2022-03 N018851-001 INDOMETHACIN 25MG CAPSULE / ORAL 1984-05-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N018851-002 INDOMETHACIN 50MG CAPSULE / ORAL 1984-05-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018851-001 INDOMETHACIN 25MG CAPSULE / ORAL 1984-05-18 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N018851-002 INDOMETHACIN 50MG CAPSULE / ORAL 1984-05-18 782e0a99824c…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded INDOMETHACIN ACTIVE INGREDIENT XXE1CET956 INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 INDOMETHACIN ACTIVE MOIETY XXE1CET956 INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 GELATIN INACTIVE INGREDIENT 2G86QN327L INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 POVIDONE INACTIVE INGREDIENT FZ989GH94E INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 INDOMETHACIN ACTIVE INGREDIENT XXE1CET956 INDOMETHACIN CAPSULE [HERITAGE PHARMACEUTICALS INC.] 6 INDOMETHACIN ACTIVE MOIETY XXE1CET956 INDOMETHACIN CAPSULE [HERITAGE PHARMACEUTICALS INC.] 6 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH INDOMETHACIN CAPSULE [HERITAGE PHARMACEUTICALS INC.] 6 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD INDOMETHACIN CAPSULE [HERITAGE PHARMACEUTICALS INC.] 6 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY INDOMETHACIN CAPSULE [HERITAGE PHARMACEUTICALS INC.] 6 GELATIN INACTIVE INGREDIENT 2G86QN327L INDOMETHACIN CAPSULE [HERITAGE PHARMACEUTICALS INC.] 6 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X INDOMETHACIN CAPSULE [HERITAGE PHARMACEUTICALS INC.] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 INDOMETHACIN CAPSULE [HERITAGE PHARMACEUTICALS INC.] 6 POVIDONE INACTIVE INGREDIENT FZ989GH94E INDOMETHACIN CAPSULE [HERITAGE PHARMACEUTICALS INC.] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 INDOMETHACIN CAPSULE [HERITAGE PHARMACEUTICALS INC.] 6 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J INDOMETHACIN CAPSULE [HERITAGE PHARMACEUTICALS INC.] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ INDOMETHACIN CAPSULE [HERITAGE PHARMACEUTICALS INC.] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP INDOMETHACIN CAPSULE [HERITAGE PHARMACEUTICALS INC.] 6 INDOMETHACIN ACTIVE INGREDIENT XXE1CET956 INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK] 2 INDOMETHACIN ACTIVE INGREDIENT XXE1CET956 INDOMETHACIN CAPSULE [PROFICIENT RX LP] 2 INDOMETHACIN ACTIVE MOIETY XXE1CET956 INDOMETHACIN CAPSULE [PROFICIENT RX LP] 2 INDOMETHACIN ACTIVE MOIETY XXE1CET956 INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK] 2 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH INDOMETHACIN CAPSULE [PROFICIENT RX LP] 2 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD INDOMETHACIN CAPSULE [PROFICIENT RX LP] 2 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK] 2 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY INDOMETHACIN CAPSULE [PROFICIENT RX LP] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L INDOMETHACIN CAPSULE [PROFICIENT RX LP] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X INDOMETHACIN CAPSULE [PROFICIENT RX LP] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 INDOMETHACIN CAPSULE [PROFICIENT RX LP] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 INDOMETHACIN CAPSULE [PROFICIENT RX LP] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J INDOMETHACIN CAPSULE [PROFICIENT RX LP] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ INDOMETHACIN CAPSULE [PROFICIENT RX LP] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP INDOMETHACIN CAPSULE [PROFICIENT RX LP] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK] 2 INDOMETHACIN ACTIVE INGREDIENT XXE1CET956 INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 INDOMETHACIN ACTIVE MOIETY XXE1CET956 INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP INDOMETHACIN CAPSULE [REBEL DISTRIBUTORS CORP] 1
DailyMed RxNorm Mappings#