NDC 42367-202

Argatroban

Argatroban

Argatroban is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Eagle Pharmaceuticals, Inc.. The primary component is Argatroban.

Product ID42367-202_426609c2-4ee5-44f0-88b3-862f15acc1b8
NDC42367-202
Product TypeHuman Prescription Drug
Proprietary NameArgatroban
Generic NameArgatroban
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2011-09-06
Marketing CategoryNDA / NDA
Application NumberNDA022434
Labeler NameEagle Pharmaceuticals, Inc.
Substance NameARGATROBAN
Active Ingredient Strength1 mg/mL
Pharm ClassesAnti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 42367-202-07

1 VIAL, SINGLE-USE in 1 CARTON (42367-202-07) > 50 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2013-07-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42367-202-84 [42367020284]

Argatroban INJECTION
Marketing CategoryNDA
Application NumberNDA022434
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-02-03

NDC 42367-202-07 [42367020207]

Argatroban INJECTION
Marketing CategoryNDA
Application NumberNDA022434
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-07-17

Drug Details

Active Ingredients

IngredientStrength
ARGATROBAN1 mg/mL

OpenFDA Data

SPL SET ID:34fb6cda-e236-4803-b599-a9b048d33513
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1804735
  • PHarm Class EPC
  • Direct Thrombin Inhibitor [EPC]
  • Anti-coagulant [EPC]
  • UPC Code
  • 0342367202070
  • NUI Code
  • N0000175518
  • N0000009963
  • N0000175980
  • Pharmacological Class

    • Anti-coagulant [EPC]
    • Direct Thrombin Inhibitor [EPC]
    • Thrombin Inhibitors [MoA]

    NDC Crossover Matching brand name "Argatroban" or generic name "Argatroban"

    NDCBrand NameGeneric Name
    0078-0930ARGATROBANargatroban
    0143-9288ArgatrobanArgatroban
    0143-9377ArgatrobanArgatroban
    0143-9559ArgatrobanArgatroban
    0143-9674ArgatrobanArgatroban
    0409-1140ArgatrobanArgatroban
    0781-3285ArgatrobanArgatroban
    0781-3314ArgatrobanArgatroban
    0781-9314ArgatrobanArgatroban
    16729-430ARGATROBANArgatroban
    25021-414ArgatrobanArgatroban
    42023-182ArgatrobanArgatroban
    42367-202ArgatrobanArgatroban
    42367-203ArgatrobanArgatroban
    55150-241ArgatrobanArgatroban
    63323-526ArgatrobanArgatroban
    68083-141ArgatrobanArgatroban
    70121-1037ArgatrobanArgatroban
    67457-212ArgatrobanArgatroban
    65145-126ARGATROBANARGATROBAN

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