Home NDC 65219-429 Argatroban
Product NDC 65219-429
11-digit product format 652190429
Labeler code 65219
Product ID 65219-429_c650fddc-9627-4dc0-af04-8a7d6e423da9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Argatroban
Dosage form INJECTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA214235
Marketing category ANDA
Marketing start 2021-05-24
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 A214235-001 ARGATROBAN ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214235-001 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.
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 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214235-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2021-01-21 a50c72e98297…
Observed Orange Book normalized TE history# 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 65219-429-50 Argatroban 1 in 1 CARTON INJECTION 1 3 65219-429-50 Argatroban 50 mL in 1 VIAL INJECTION 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-429 ARGATROBAN INJECTION [FRESENIUS KABI USA, LLC] 2 Current NDC, Legacy NDC, 2 package rows 20231025_dfa5d325-f609-4c9a-aaae-1a17df47da1e.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 65219-429-50 65219042950 1 VIAL in 1 CARTON (65219-429-50) / 50 mL in 1 VIAL 1 vial 2021-05-24 0000-00-00 No No Current