Home NDC 68083-141 Argatroban
Product NDC 68083-141
11-digit product format 680830141
Labeler code 68083
Product ID 68083-141_c07a92fe-93d4-456d-8df2-ce14959116b6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Argatroban
Dosage form SOLUTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA205570
Marketing category ANDA
Marketing start 2017-05-26
Substance ARGATROBAN
Active strength 125 mg/125mL
Pharmacologic classes Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]
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 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 A205570-001 ARGATROBAN IN SODIUM CHLORIDE ARGATROBAN 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205570-001 AP
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 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205570-001 ARGATROBAN IN SODIUM CHLORIDE 125MG/125ML (1MG/ML) INJECTABLE / INTRAVENOUS AP 2017-05-22 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Argatroban
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ARGATROBAN 125 mg/125mL
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 1804737 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 68083-141-01 Argatroban 125 mL in 1 VIAL SOLUTION 125 5 68083-141-02 Argatroban 2 in 1 CARTON SOLUTION 2 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-141 ARGATROBAN SOLUTION [GLAND PHARMA LIMITED] 4 Current NDC, Legacy NDC, 2 package rows 20170526_e5ccb93c-f411-4e7e-824a-4a592b4947ec.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 Units Marketing start Marketing end Sample Exclude flag Status 68083-141-01 68083014101 125 mL in 1 VIAL 125 ml Historical 68083-141-02 68083014102 2 VIAL in 1 CARTON (68083-141-02) / 125 mL in 1 VIAL (68083-141-01) 2 vial 2017-05-26 0000-00-00 No No Current