argatroban

Generic: argatroban

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name argatroban
Generic Name argatroban
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

argatroban 50 mg/50mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-241
Product ID 55150-241_22fd3221-0cbe-4fc2-b4ca-e93faa99b8c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209552
Listing Expiration 2026-12-31
Marketing Start 2018-11-27

Pharmacologic Class

Established (EPC)
anti-coagulant [epc] direct thrombin inhibitor [epc]
Mechanism of Action
thrombin inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150241
Hyphenated Format 55150-241

Supplemental Identifiers

RxCUI
1804735
UPC
0355150241019
UNII
IY90U61Z3S
NUI
N0000175980 N0000175518 N0000009963

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name argatroban (source: ndc)
Generic Name argatroban (source: ndc)
Application Number NDA209552 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/50mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-241-01) / 50 mL in 1 VIAL, SINGLE-DOSE
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-241-10) / 50 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

55150-241-01 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-241-01) / 50 mL in 1 VIAL, SINGLE-DOSE 55150-241-10 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-241-10) / 50 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

argatroban (50 mg/50mL)

Linked Drug Pages (1)

Argatroban ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "22fd3221-0cbe-4fc2-b4ca-e93faa99b8c0", "openfda": {"nui": ["N0000175980", "N0000175518", "N0000009963"], "upc": ["0355150241019"], "unii": ["IY90U61Z3S"], "rxcui": ["1804735"], "spl_set_id": ["d9b975bd-e3f4-466e-96ca-7bef7899506d"], "pharm_class_epc": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]"], "pharm_class_moa": ["Thrombin Inhibitors [MoA]"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (55150-241-01)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-241-01", "marketing_start_date": "20181127"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (55150-241-10)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-241-10", "marketing_start_date": "20181127"}], "brand_name": "Argatroban", "product_id": "55150-241_22fd3221-0cbe-4fc2-b4ca-e93faa99b8c0", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "55150-241", "generic_name": "Argatroban", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Argatroban", "active_ingredients": [{"name": "ARGATROBAN", "strength": "50 mg/50mL"}], "application_number": "NDA209552", "marketing_category": "NDA", "marketing_start_date": "20181127", "listing_expiration_date": "20261231"}