Home NDC 61919-164 INDOMETHACIN
Product NDC 61919-164
11-digit product format 619190164
Labeler code 61919
Product ID 61919-164_151f8422-70b3-cf70-e063-6294a90a90fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name INDOMETHACIN
Dosage form CAPSULE
Route ORAL
Labeler DIRECT RX
Application ANDA091276
Marketing category ANDA
Marketing start 2017-04-20
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 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.
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 61919-164-21 INDOMETHACIN 21 in 1 BOTTLE CAPSULE 21 7 61919-164-30 INDOMETHACIN 30 in 1 BOTTLE CAPSULE 30 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61919-164 INDOMETHACIN CAPSULE [DIRECT RX] 7 Current NDC, Legacy NDC, 2 package rows 20240403_4d9a253a-f014-4fab-e054-00144ff8d46c.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.
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 61919-164-21 61919016421 21 CAPSULE in 1 BOTTLE (61919-164-21) 21 capsule 2017-04-20 0000-00-00 No No Current 61919-164-30 61919016430 30 CAPSULE in 1 BOTTLE (61919-164-30) 30 capsule 2017-04-20 0000-00-00 No No Current