NDC 63323-526

Argatroban

Argatroban

Argatroban is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Argatroban.

• Product ID: 63323-526_38530ce5-b666-4502-83f1-63e553bd86b4
• NDC: 63323-526
• Product Type: Human Prescription Drug
• Proprietary Name: Argatroban
• Generic Name: Argatroban
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2015-03-23
• Marketing Category: NDA / NDA
• Application Number: NDA201811
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: ARGATROBAN
• Active Ingredient Strength: 100 mg/mL
• Pharm Classes: Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 63323-526-03

1 VIAL, SINGLE-DOSE in 1 CARTON (63323-526-03) > 2.5 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2015-03-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-526-03 [63323052603]

Argatroban INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA201811
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-03-23

Drug Details

Active Ingredients

Ingredient	Strength
ARGATROBAN	100 mg/mL

OpenFDA Data

• SPL SET ID: e1cf0ad0-0b23-497e-9deb-3de3bf48be44
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • IY90U61Z3S
• 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"

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