Home NDC 55150-241 Argatroban
Product NDC 55150-241
11-digit product format 551500241
Labeler code 55150
Product ID 55150-241_22fd3221-0cbe-4fc2-b4ca-e93faa99b8c0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Argatroban
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Eugia US LLC
Application NDA209552
Marketing category NDA
Marketing start 2018-11-27
Substance ARGATROBAN
Active strength 50 mg/50mL
Pharmacologic classes Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]
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 N209552-001 ARGATROBAN IN SODIUM CHLORIDE ARGATROBAN 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27
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 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N209552-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS 2018-11-27 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Argatroban
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ARGATROBAN 50 mg/50mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination IY90U61Z3S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1804735 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 55150-241-01 Argatroban 50 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 50 3 55150-241-01 Argatroban 1 in 1 CARTON INJECTION, SOLUTION 1 3 55150-241-10 Argatroban 10 in 1 CARTON INJECTION, SOLUTION 10 3 55150-241-10 Argatroban 50 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-241 ARGATROBAN INJECTION, SOLUTION [EUGIA US LLC] 3 Current NDC, Legacy NDC, 4 package rows 20230804_d9b975bd-e3f4-466e-96ca-7bef7899506d.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.
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 55150-241-01 55150024101 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-241-01) / 50 mL in 1 VIAL, SINGLE-DOSE 2018-11-27 0000-00-00 No No Current 55150-241-10 55150024110 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-241-10) / 50 mL in 1 VIAL, SINGLE-DOSE 2018-11-27 0000-00-00 No No Current