NDC 68083-141

Argatroban

Argatroban

Argatroban is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Argatroban.

• Product ID: 68083-141_69efc0d6-1280-4920-b920-c56bfc353602
• NDC: 68083-141
• Product Type: Human Prescription Drug
• Proprietary Name: Argatroban
• Generic Name: Argatroban
• Dosage Form: Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-05-26
• Marketing Category: ANDA / ANDA
• Application Number: ANDA205570
• Labeler Name: Gland Pharma Limited
• Substance Name: ARGATROBAN
• Active Ingredient Strength: 125 mg/125mL
• Pharm Classes: Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 68083-141-02

2 VIAL in 1 CARTON (68083-141-02) > 125 mL in 1 VIAL (68083-141-01)

• Marketing Start Date: 2017-05-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68083-141-01 [68083014101]

Argatroban SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA205570
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-05-26

NDC 68083-141-02 [68083014102]

Argatroban SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA205570
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-05-26

Drug Details

Active Ingredients

Ingredient	Strength
ARGATROBAN	125 mg/125mL

OpenFDA Data

• SPL SET ID: e5ccb93c-f411-4e7e-824a-4a592b4947ec
• Manufacturer:
  • Gland Pharma Limited
• UNII:
  • IY90U61Z3S
• RxNorm Concept Unique ID - RxCUI:
  • 1804737
• 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]
• Anti-coagulant [EPC]
• Direct Thrombin Inhibitor [EPC]
• Thrombin Inhibitors [MoA]

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

NDC	Brand Name	Generic Name
0078-0930	ARGATROBAN	argatroban
0143-9288	Argatroban	Argatroban
0143-9377	Argatroban	Argatroban
0143-9559	Argatroban	Argatroban
0143-9674	Argatroban	Argatroban
0409-1140	Argatroban	Argatroban
0781-3285	Argatroban	Argatroban
0781-3314	Argatroban	Argatroban
0781-9314	Argatroban	Argatroban
16729-430	ARGATROBAN	Argatroban
25021-414	Argatroban	Argatroban
42023-182	Argatroban	Argatroban
42367-202	Argatroban	Argatroban
42367-203	Argatroban	Argatroban
55150-241	Argatroban	Argatroban
63323-526	Argatroban	Argatroban
68083-141	Argatroban	Argatroban
70121-1037	Argatroban	Argatroban
67457-212	Argatroban	Argatroban
65145-126	ARGATROBAN	ARGATROBAN