argatroban

Generic: argatroban

Labeler: par health usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name argatroban
Generic Name argatroban
Labeler par health usa, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

argatroban 250 mg/2.5mL

Manufacturer
Par Health USA, LLC

Identifiers & Regulatory

Product NDC 42023-182
Product ID 42023-182_369ba938-a680-4b30-9377-e997614d5fee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091665
Listing Expiration 2026-12-31
Marketing Start 2015-06-01

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 42023182
Hyphenated Format 42023-182

Supplemental Identifiers

RxCUI
308351
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 ANDA091665 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 250 mg/2.5mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (42023-182-01) / 2.5 mL in 1 VIAL
source: ndc

Packages (1)

42023-182-01 1 VIAL in 1 CARTON (42023-182-01) / 2.5 mL in 1 VIAL

Ingredients (1)

argatroban (250 mg/2.5mL)

Linked Drug Pages (2)

Argatroban ndc-match (0.9) Argatroban ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "369ba938-a680-4b30-9377-e997614d5fee", "openfda": {"nui": ["N0000175980", "N0000175518", "N0000009963"], "unii": ["IY90U61Z3S"], "rxcui": ["308351"], "spl_set_id": ["d4e5238f-2378-424e-bda2-f1a2cf874041"], "pharm_class_epc": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]"], "pharm_class_moa": ["Thrombin Inhibitors [MoA]"], "manufacturer_name": ["Par Health USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (42023-182-01)  / 2.5 mL in 1 VIAL", "package_ndc": "42023-182-01", "marketing_start_date": "20150601"}], "brand_name": "Argatroban", "product_id": "42023-182_369ba938-a680-4b30-9377-e997614d5fee", "dosage_form": "INJECTION", "pharm_class": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "42023-182", "generic_name": "Argatroban", "labeler_name": "Par Health USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Argatroban", "active_ingredients": [{"name": "ARGATROBAN", "strength": "250 mg/2.5mL"}], "application_number": "ANDA091665", "marketing_category": "ANDA", "marketing_start_date": "20150601", "listing_expiration_date": "20261231"}