Home NDC 63323-659 Indomethacin
Product NDC 63323-659
11-digit product format 633230659
Labeler code 63323
Product ID 63323-659_18ca75fc-a45c-42a4-b966-9d3ae4821de8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name INDOMETHACIN
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application NDA022536
Marketing category NDA
Marketing start 2010-03-19
Substance INDOMETHACIN
Active strength 1 mg/mL
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 42 .
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 N022536-001 INDOMETHACIN INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17
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 · 42 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 2026-08-18 06:07:40 2026-07 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022536-001 INDOMETHACIN EQ 1MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 2010-03-17 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Indomethacin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength INDOMETHACIN 1 mg/mL
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 346508 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 63323-659-03 Indomethacin 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 8 63323-659-03 Indomethacin 1 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 8 63323-659-09 Indomethacin 1 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 5 63323-659-09 Indomethacin 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 5 63323-659-94 Indomethacin 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 5 63323-659-94 Indomethacin 1 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded INDOMETHACIN ACTIVE INGREDIENT XXE1CET956 INDOMETHACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 4 INDOMETHACIN ACTIVE MOIETY XXE1CET956 INDOMETHACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 4 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I INDOMETHACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 4 SODIUM PHOSPHATE, DIBASIC INACTIVE INGREDIENT GR686LBA74 INDOMETHACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 4 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW INDOMETHACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 4 INDOMETHACIN ACTIVE INGREDIENT XXE1CET956 INDOMETHACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 INDOMETHACIN ACTIVE INGREDIENT XXE1CET956 INDOMETHACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 INDOMETHACIN ACTIVE MOIETY XXE1CET956 INDOMETHACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 INDOMETHACIN ACTIVE MOIETY XXE1CET956 INDOMETHACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I INDOMETHACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I INDOMETHACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 SODIUM PHOSPHATE, DIBASIC INACTIVE INGREDIENT GR686LBA74 INDOMETHACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 SODIUM PHOSPHATE, DIBASIC INACTIVE INGREDIENT GR686LBA74 INDOMETHACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW INDOMETHACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW INDOMETHACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-659 INDOMETHACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] 7 Current NDC, Legacy NDC, 2 package rows 20230603_ec482425-358c-4500-8f5d-79c1379c1fa8.zip 63323-659 INDOMETHACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20230727_30e38747-c553-4e2d-bc23-634e1dd90b8d.zip 63323-659 INDOMETHACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20230713_dd5caa3f-3c09-4034-bf43-2df80c61c07b.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 · 3 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 63323-659-03 63323065903 1 VIAL in 1 CARTON (63323-659-03) / 1 mL in 1 VIAL 1 vial 2010-03-19 0000-00-00 No No Current 63323-659-09 63323065909 1 VIAL in 1 CARTON (63323-659-09) / 1 mL in 1 VIAL 1 vial 2010-03-19 0000-00-00 No No Current 63323-659-94 63323065994 1 VIAL in 1 CARTON (63323-659-94) / 1 mL in 1 VIAL 1 vial 2010-03-19 0000-00-00 No No Current