Home NDC 69344-101 Indocin
Product NDC 69344-101
11-digit product format 693440101
Labeler code 69344
Product ID 69344-101_58959f55-f324-4433-97fc-c3b1b7c199be
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name indomethacin
Dosage form SUSPENSION
Route ORAL
Labeler Zyla Life Sciences US LLC
Application NDA018332
Marketing category NDA
Marketing start 2019-02-04
Substance INDOMETHACIN
Active strength 25 mg/5mL
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 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018332-001 INDOCIN INDOMETHACIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018332-001 AB
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 2 · 41 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 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL AB RLD, RS 1985-10-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018332-001 INDOCIN 25MG/5ML SUSPENSION / ORAL RLD, RS 1985-10-10 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Indocin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength INDOMETHACIN 25 mg/5mL
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 206971 Internal RxNorm lookup 310991 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 69344-101-01 Indocin 237 mL in 1 BOTTLE, GLASS SUSPENSION 237 5 69344-101-01 Indocin 1 in 1 CARTON SUSPENSION 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69344-101 INDOCIN (INDOMETHACIN) SUSPENSION [ZYLA LIFE SCIENCES US LLC] 5 Current NDC, Legacy NDC, 2 package rows 20241219_73878376-1d24-423b-9f37-3666e83c95da.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 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Indocin INDOMETHACIN Zyla Life Sciences US LLC 73878376-1d24-423b-9f37-3666e83c95da 2024-12-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 018332 application number: NDA018332 ndc (product): 69344-101
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69344-101-01 69344010101 1 BOTTLE, GLASS in 1 CARTON (69344-101-01) / 237 mL in 1 BOTTLE, GLASS 2019-02-04 0000-00-00 No No Current