Home NDC 67457-212 Argatroban
Product NDC 67457-212
11-digit product format 674570212
Labeler code 67457
Product ID 67457-212_08b6fbe4-ad4f-45eb-aad5-0b6bac026652
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name argatroban
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA202626
Marketing category ANDA
Marketing start 2017-11-14
Substance ARGATROBAN
Active strength 250 mg/2.5mL
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 A202626-001 ARGATROBAN ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202626-001 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 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202626-001 ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE / INJECTION AP 2014-06-30 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 250 mg/2.5mL
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 308351 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 67457-212-02 Argatroban 2.5 mL in 1 VIAL, GLASS INJECTION, SOLUTION 2.5 6 67457-212-02 Argatroban 1 in 1 CARTON INJECTION, SOLUTION 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-212 ARGATROBAN INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] 5 Current NDC, Legacy NDC, 2 package rows 20210729_b0dedf95-8395-46bf-b94a-dcf2dd085942.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 67457-212-02 67457021202 1 VIAL, GLASS in 1 CARTON (67457-212-02) / 2.5 mL in 1 VIAL, GLASS 2017-11-14 0000-00-00 No No Current