NDC 0078-0930

ARGATROBAN

Argatroban

ARGATROBAN is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Argatroban.

Product ID0078-0930_0f662dcc-7e4e-491a-9b63-bf077782aa30
NDC0078-0930
Product TypeHuman Prescription Drug
Proprietary NameARGATROBAN
Generic NameArgatroban
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-02-02
Marketing CategoryNDA / NDA
Application NumberNDA020883
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameARGATROBAN
Active Ingredient Strength100 mg/mL
Pharm ClassesAnti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0078-0930-61

1 VIAL in 1 CARTON (0078-0930-61) > 2.5 mL in 1 VIAL
Marketing Start Date2018-02-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0930-61 [00078093061]

ARGATROBAN INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020883
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-02-02

Drug Details

Active Ingredients

IngredientStrength
ARGATROBAN100 mg/mL

OpenFDA Data

SPL SET ID:5559541e-a8c7-4ef1-a308-8b07795f2be5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308351
  • PHarm Class EPC
  • Direct Thrombin Inhibitor [EPC]
  • Anti-coagulant [EPC]
  • 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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