argatroban

Generic: argatroban

Labeler: mullan pharmaceutical inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name argatroban
Generic Name argatroban
Labeler mullan pharmaceutical inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

argatroban 50 mg/50mL

Manufacturer
Mullan Pharmaceutical Inc.

Identifiers & Regulatory

Product NDC 83301-0062
Product ID 83301-0062_8b45a05d-47a6-4a64-b232-108bd7185eba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217848
Listing Expiration 2026-12-31
Marketing Start 2026-01-01

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 833010062
Hyphenated Format 83301-0062

Supplemental Identifiers

RxCUI
1804735
UPC
0383301006217
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 ANDA217848 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/50mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (83301-0062-1) / 50 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

83301-0062-1 1 VIAL, SINGLE-DOSE in 1 CARTON (83301-0062-1) / 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": "8b45a05d-47a6-4a64-b232-108bd7185eba", "openfda": {"nui": ["N0000175980", "N0000175518", "N0000009963"], "upc": ["0383301006217"], "unii": ["IY90U61Z3S"], "rxcui": ["1804735"], "spl_set_id": ["50e21062-f021-40f2-ad11-896f46378a15"], "pharm_class_epc": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]"], "pharm_class_moa": ["Thrombin Inhibitors [MoA]"], "manufacturer_name": ["Mullan Pharmaceutical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (83301-0062-1)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "83301-0062-1", "marketing_start_date": "20260101"}], "brand_name": "Argatroban", "product_id": "83301-0062_8b45a05d-47a6-4a64-b232-108bd7185eba", "dosage_form": "INJECTION", "pharm_class": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "83301-0062", "generic_name": "Argatroban", "labeler_name": "Mullan Pharmaceutical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Argatroban", "active_ingredients": [{"name": "ARGATROBAN", "strength": "50 mg/50mL"}], "application_number": "ANDA217848", "marketing_category": "ANDA", "marketing_start_date": "20260101", "listing_expiration_date": "20261231"}