NDC 0781-3314

Argatroban

Argatroban

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

• Product ID: 0781-3314_413b7705-abc3-4b8d-bf40-3f00838b77e0
• NDC: 0781-3314
• Product Type: Human Prescription Drug
• Proprietary Name: Argatroban
• Generic Name: Argatroban
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2011-09-06
• Marketing Category: NDA / NDA
• Application Number: NDA022434
• Labeler Name: Sandoz Inc
• Substance Name: ARGATROBAN
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0781-3314-95

10 CARTON in 1 CARTON (0781-3314-95) > 1 VIAL, SINGLE-USE in 1 CARTON (0781-3314-91) > 50 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2017-02-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0781-3314-91 [00781331491]

Argatroban INJECTION

• Marketing Category: NDA
• Application Number: NDA022434
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-09-06

NDC 0781-3314-95 [00781331495]

Argatroban INJECTION

• Marketing Category: NDA
• Application Number: NDA022434
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-02-03

Drug Details

Active Ingredients

Ingredient	Strength
ARGATROBAN	1 mg/mL

OpenFDA Data

• SPL SET ID: 641c4c2b-87a3-44ca-a126-f83a4d58e988
• Manufacturer:
  • Sandoz Inc
• UNII:
  • IY90U61Z3S
• RxNorm Concept Unique ID - RxCUI:
  • 1804735
• PHarm Class EPC:
  • Direct Thrombin Inhibitor [EPC]
  • Anti-coagulant [EPC]
• UPC Code:
  • 0307813314912
  • 0307813314950
• 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