NDC 0143-9674

Argatroban

Argatroban

Argatroban is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp. The primary component is Argatroban.

Product ID0143-9674_09b26b92-4fc2-4969-8e79-956fd6c325b6
NDC0143-9674
Product TypeHuman Prescription Drug
Proprietary NameArgatroban
Generic NameArgatroban
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2012-01-05
Marketing CategoryNDA / NDA
Application NumberNDA203049
Labeler NameWest-Ward Pharmaceuticals Corp
Substance NameARGATROBAN
Active Ingredient Strength250 mg/2.5mL
Pharm ClassesAnti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0143-9674-01

2.5 mL in 1 VIAL (0143-9674-01)
Marketing Start Date2012-01-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0143-9674-01 [00143967401]

Argatroban INJECTION
Marketing CategoryNDA
Application NumberNDA203049
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-01-05

Drug Details

Active Ingredients

IngredientStrength
ARGATROBAN250 mg/2.5mL

OpenFDA Data

SPL SET ID:0cdf3f67-5bf3-4d58-b330-03febdc652bf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1804735
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.