Home NDC 72865-149 Indomethacin
Product NDC 72865-149
11-digit product format 728650149
Labeler code 72865
Product ID 72865-149_f26f7451-69b2-99d7-e053-2a95a90af7a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Indomethacin
Dosage form CAPSULE
Route ORAL
Labeler XLCare Pharmaceuticals Inc.
Application ANDA091240
Marketing category ANDA
Marketing start 2021-07-27
Substance INDOMETHACIN
Active strength 50 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 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 A091240-001 INDOMETHACIN INDOMETHACIN 25MG CAPSULE / ORAL AB 2011-04-12 A091240-002 INDOMETHACIN INDOMETHACIN 50MG CAPSULE / ORAL AB 2011-04-12
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 A091240-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2011-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091240-002 INDOMETHACIN 50MG CAPSULE / ORAL AB 2011-04-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091240-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2011-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091240-002 INDOMETHACIN 50MG CAPSULE / ORAL AB 2011-04-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091240-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2011-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091240-002 INDOMETHACIN 50MG CAPSULE / ORAL AB 2011-04-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091240-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2011-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091240-002 INDOMETHACIN 50MG CAPSULE / ORAL AB 2011-04-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091240-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2011-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091240-002 INDOMETHACIN 50MG CAPSULE / ORAL AB 2011-04-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091240-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2011-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091240-002 INDOMETHACIN 50MG CAPSULE / ORAL AB 2011-04-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091240-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2011-04-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091240-002 INDOMETHACIN 50MG CAPSULE / ORAL AB 2011-04-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091240-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2011-04-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091240-002 INDOMETHACIN 50MG CAPSULE / ORAL AB 2011-04-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091240-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2011-04-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091240-002 INDOMETHACIN 50MG CAPSULE / ORAL AB 2011-04-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091240-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2011-04-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091240-002 INDOMETHACIN 50MG CAPSULE / ORAL AB 2011-04-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091240-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2011-04-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091240-002 INDOMETHACIN 50MG CAPSULE / ORAL AB 2011-04-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091240-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2011-04-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091240-002 INDOMETHACIN 50MG CAPSULE / ORAL AB 2011-04-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091240-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2011-04-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091240-002 INDOMETHACIN 50MG CAPSULE / ORAL AB 2011-04-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091240-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2011-04-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091240-002 INDOMETHACIN 50MG CAPSULE / ORAL AB 2011-04-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091240-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2011-04-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091240-002 INDOMETHACIN 50MG CAPSULE / ORAL AB 2011-04-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091240-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2011-04-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091240-002 INDOMETHACIN 50MG CAPSULE / ORAL AB 2011-04-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091240-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2011-04-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091240-002 INDOMETHACIN 50MG CAPSULE / ORAL AB 2011-04-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091240-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2011-04-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091240-002 INDOMETHACIN 50MG CAPSULE / ORAL AB 2011-04-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091240-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2011-04-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091240-002 INDOMETHACIN 50MG CAPSULE / ORAL AB 2011-04-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091240-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2011-04-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091240-002 INDOMETHACIN 50MG CAPSULE / ORAL AB 2011-04-12 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.
Additional Listing Data#
Finished product Yes
Brand name base Indomethacin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength INDOMETHACIN 50 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197817 Internal RxNorm lookup 197818 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 72865-149-01 Indomethacin 100 in 1 BOTTLE CAPSULE 100 2 72865-149-05 Indomethacin 500 in 1 BOTTLE CAPSULE 500 2 72865-149-10 Indomethacin 1000 in 1 BOTTLE CAPSULE 1000 2 72865-149-30 Indomethacin 30 in 1 BOTTLE CAPSULE 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72865-149 INDOMETHACIN (INDOMETHACIN) CAPSULE [XLCARE PHARMACEUTICALS INC.] 2 Current NDC, Legacy NDC, 4 package rows 20230117_bc8a572d-e0e1-4d37-b3c4-b85415d50393.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 · 24 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Indomethacin INDOMETHACIN XLCare Pharmaceuticals Inc. bc8a572d-e0e1-4d37-b3c4-b85415d50393 2023-01-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091240 application number: ANDA091240 ndc (product): 72865-149 Indomethacin INDOMETHACIN Proficient Rx LP 66e3205b-eab1-4864-bf36-116e9d79fe3e 2023-01-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091240 application number: ANDA091240 Indomethacin INDOMETHACIN Asclemed USA, Inc. 9c15102c-b6f9-4198-b592-152160591014 2022-07-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091240 application number: ANDA091240 Indomethacin INDOMETHACIN Proficient Rx LP 8aa48212-19b0-4304-9c61-dcf4db2b19ea 2022-06-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091240 application number: ANDA091240
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 72865-149-01 72865014901 100 CAPSULE in 1 BOTTLE (72865-149-01) 100 capsule 2021-07-27 0000-00-00 No No Current 72865-149-05 72865014905 500 CAPSULE in 1 BOTTLE (72865-149-05) 500 capsule 2021-07-27 0000-00-00 No No Current 72865-149-10 72865014910 1000 CAPSULE in 1 BOTTLE (72865-149-10) 1000 capsule 2021-07-27 0000-00-00 No No Current 72865-149-30 72865014930 30 CAPSULE in 1 BOTTLE (72865-149-30) 30 capsule 2021-07-27 0000-00-00 No No Current