Home NDC 68083-568 Argatroban
Product NDC 68083-568
11-digit product format 680830568
Labeler code 68083
Product ID 68083-568_0f487fff-cf82-44ce-bc1b-c32fa7bdf1c7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Argatroban
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA217848
Marketing category ANDA
Marketing start 2023-07-31
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 A217848-001 ARGATROBAN ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2023-07-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217848-001 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 A217848-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2023-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217848-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2023-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217848-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2023-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217848-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2023-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217848-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2023-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217848-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2023-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217848-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2023-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217848-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2023-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217848-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2023-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217848-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2023-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217848-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2023-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217848-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2023-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217848-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2023-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217848-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2023-07-31 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217848-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2023-07-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217848-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2023-07-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217848-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2023-07-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217848-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2023-07-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217848-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2023-07-31 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217848-001 ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE / INJECTION AP 2023-07-31 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Argatroban
Listing expiration 2027-12-31 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 68083-568-01 Argatroban 50 mL in 1 VIAL INJECTION, SOLUTION 50 3 68083-568-01 Argatroban 1 in 1 CARTON INJECTION, SOLUTION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-568 ARGATROBAN INJECTION, SOLUTION [GLAND PHARMA LIMITED] 3 Current NDC, 2 package rows 20230803_270dbb59-e080-4a64-91d9-a68bed4bd2e5.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 Sample Exclude flag Status 68083-568-01 68083056801 1 VIAL in 1 CARTON (68083-568-01) / 50 mL in 1 VIAL 1 vial 2023-07-31 No No Current