Home NDC 71205-215 Indomethacin
Product NDC 71205-215
11-digit product format 712050215
Labeler code 71205
Product ID 71205-215_057302f7-9a50-42f4-8f96-ce23f409bc4c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Indomethacin
Dosage form CAPSULE
Route ORAL
Labeler Proficient Rx LP
Application ANDA091240
Marketing category ANDA
Marketing start 2011-11-01
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 2027-12-31
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 2027-12-31 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 71205-215-20 Indomethacin 20 in 1 BOTTLE CAPSULE 20 5 71205-215-30 Indomethacin 30 in 1 BOTTLE CAPSULE 30 5 71205-215-60 Indomethacin 60 in 1 BOTTLE CAPSULE 60 5 71205-215-90 Indomethacin 90 in 1 BOTTLE CAPSULE 90 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-215 INDOMETHACIN CAPSULE [PROFICIENT RX LP] 5 Current NDC, Legacy NDC, 4 package rows 20220702_8aa48212-19b0-4304-9c61-dcf4db2b19ea.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 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 ndc (product): 71205-215
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 71205-215-20 71205021520 20 CAPSULE in 1 BOTTLE (71205-215-20) 20 capsule 2019-09-01 0000-00-00 No No Current 71205-215-30 71205021530 30 CAPSULE in 1 BOTTLE (71205-215-30) 30 capsule 2019-02-01 0000-00-00 No No Current 71205-215-60 71205021560 60 CAPSULE in 1 BOTTLE (71205-215-60) 60 capsule 2019-02-01 0000-00-00 No No Current 71205-215-90 71205021590 90 CAPSULE in 1 BOTTLE (71205-215-90) 90 capsule 2019-02-01 0000-00-00 No No Current