Home NDC 50090-0050 Indomethacin
Product NDC 50090-0050
11-digit product format 500900050
Labeler code 50090
Product ID 50090-0050_9ba7aeb2-1e90-40a4-8db6-fd9fae18c84a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Indomethacin
Dosage form CAPSULE
Route ORAL
Labeler A-S Medication Solutions
Application ANDA091240
Marketing category ANDA
Marketing start 2016-05-19
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 2027-12-31
Current FDA listing Yes 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-0050 50090-0050-5 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-0050 50090-0050-5 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 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 · 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 A091240-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2011-04-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091240-002 INDOMETHACIN 50MG CAPSULE / ORAL AB 2011-04-12 c2088c7a36db…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…
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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength INDOMETHACIN 50 mg/1
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 50090-0050-0 2023-02-07 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-0 2023-02-07 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-0 2023-02-07 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-0 2023-02-07 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-0 2023-02-07 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-0 2023-02-07 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-1 2023-02-07 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-1 2023-02-07 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-1 2023-02-07 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-1 2023-02-07 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-1 2023-02-07 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-1 2023-02-07 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-3 2023-02-07 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-3 2023-02-07 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-3 2023-02-07 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-3 2023-02-07 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-3 2023-02-07 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-3 2023-02-07 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-5 2023-02-07 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-5 2023-02-07 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-5 2023-02-07 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-5 2023-02-07 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-5 2023-02-07 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-5 2023-02-07 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-0 2023-01-30 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-0 2023-01-30 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-0 2023-01-30 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-0 2023-01-30 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-0 2023-01-30 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-0 2023-01-30 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-1 2023-01-30 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-1 2023-01-30 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-1 2023-01-30 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-1 2023-01-30 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-1 2023-01-30 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-1 2023-01-30 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-3 2023-01-30 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-3 2023-01-30 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-3 2023-01-30 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-3 2023-01-30 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-3 2023-01-30 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-3 2023-01-30 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-5 2023-01-30 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-5 2023-01-30 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-5 2023-01-30 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-5 2023-01-30 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-5 2023-01-30 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965 50090-0050-5 2023-01-30 These highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN Capsules, for oral use Initial U.S. Approval: 1965
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-0050-0 Indomethacin 21 in 1 BOTTLE CAPSULE 21 33 50090-0050-1 Indomethacin 30 in 1 BOTTLE CAPSULE 30 33 50090-0050-3 Indomethacin 90 in 1 BOTTLE CAPSULE 90 33 50090-0050-5 Indomethacin 15 in 1 BOTTLE CAPSULE 15 33
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-0050 INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS] 27 Current NDC, Legacy NDC, 4 package rows 20250403_d2997707-1541-4f5d-8c8d-70b0a13be8b2.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
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 50090-0050-0 50090005000 21 CAPSULE in 1 BOTTLE (50090-0050-0) 21 capsule 2016-05-19 0000-00-00 No No Current 50090-0050-1 50090005001 30 CAPSULE in 1 BOTTLE (50090-0050-1) 30 capsule 2016-05-19 0000-00-00 No No Current 50090-0050-3 50090005003 90 CAPSULE in 1 BOTTLE (50090-0050-3) 90 capsule 2016-05-19 0000-00-00 No No Current 50090-0050-5 50090005005 15 in 1 BOTTLE Historical