Home NDC 16729-430 ARGATROBAN
Product NDC 16729-430
11-digit product format 167290430
Labeler code 16729
Product ID 16729-430_525900ef-aa6b-7f43-e063-6294a90a27de
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Argatroban
Dosage form INJECTION
Route INTRAVENOUS
Labeler Accord Healthcare Inc.
Application NDA212035
Marketing category NDA
Marketing start 2021-10-07
Substance ARGATROBAN
Active strength 1 mg/mL
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 N212035-001 ARGATROBAN IN SODIUM CHLORIDE ARGATROBAN 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07
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.
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 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212035-001 ARGATROBAN IN SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-06-07 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base ARGATROBAN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ARGATROBAN 1 mg/mL
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 16729-430-11 ARGATROBAN 1 in 1 CARTON INJECTION 1 8 16729-430-11 ARGATROBAN 50 mL in 1 VIAL, SINGLE-USE INJECTION 50 8 16729-430-43 ARGATROBAN 50 mL in 1 VIAL, SINGLE-USE INJECTION 50 8 16729-430-43 ARGATROBAN 10 in 1 CARTON INJECTION 10 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16729-430 ARGATROBAN INJECTION [ACCORD HEALTHCARE INC.] 7 Current NDC, Legacy NDC, 4 package rows 20241006_46cdf9e6-839c-49c8-9ee1-c30cfdd9368d.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 16729-430-11 16729043011 1 VIAL, SINGLE-USE in 1 CARTON (16729-430-11) / 50 mL in 1 VIAL, SINGLE-USE 2021-10-07 0000-00-00 No No Current 16729-430-43 16729043043 10 VIAL, SINGLE-USE in 1 CARTON (16729-430-43) / 50 mL in 1 VIAL, SINGLE-USE 2021-10-07 0000-00-00 No No Current