argatroban

Generic: argatroban

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name argatroban
Generic Name argatroban
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

argatroban 50 mg/50mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-568
Product ID 68083-568_0f487fff-cf82-44ce-bc1b-c32fa7bdf1c7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217848
Listing Expiration 2026-12-31
Marketing Start 2023-07-31

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 68083568
Hyphenated Format 68083-568

Supplemental Identifiers

RxCUI
1804735
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 in 1 CARTON (68083-568-01) / 50 mL in 1 VIAL
source: ndc

Packages (1)

68083-568-01 1 VIAL in 1 CARTON (68083-568-01) / 50 mL in 1 VIAL

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": "0f487fff-cf82-44ce-bc1b-c32fa7bdf1c7", "openfda": {"nui": ["N0000175980", "N0000175518", "N0000009963"], "unii": ["IY90U61Z3S"], "rxcui": ["1804735"], "spl_set_id": ["270dbb59-e080-4a64-91d9-a68bed4bd2e5"], "pharm_class_epc": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]"], "pharm_class_moa": ["Thrombin Inhibitors [MoA]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68083-568-01)  / 50 mL in 1 VIAL", "package_ndc": "68083-568-01", "marketing_start_date": "20230731"}], "brand_name": "Argatroban", "product_id": "68083-568_0f487fff-cf82-44ce-bc1b-c32fa7bdf1c7", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "68083-568", "generic_name": "Argatroban", "labeler_name": "Gland Pharma Limited", "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": "20230731", "listing_expiration_date": "20261231"}