NDC 65293-015

Orbactiv

Oritavancin

Orbactiv is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by The Medicines Company. The primary component is Oritavancin.

• Product ID: 65293-015_60ef4da8-d132-f2fe-e053-2a91aa0a4005
• NDC: 65293-015
• Product Type: Human Prescription Drug
• Proprietary Name: Orbactiv
• Generic Name: Oritavancin
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2014-09-01
• Marketing End Date: 2021-06-30
• Marketing Category: NDA / NDA
• Application Number: NDA206334
• Labeler Name: The Medicines Company
• Substance Name: ORITAVANCIN
• Active Ingredient Strength: 400 mg/1
• Pharm Classes: Lipoglycopeptide Antibacterial [EPC],Lipoglycopeptides [EXT],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA]
• NDC Exclude Flag: N

Packaging

NDC 65293-015-03

3 VIAL, GLASS in 1 CARTON (65293-015-03) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (65293-015-01)

• Marketing Start Date: 2014-09-01
• Marketing End Date: 2021-06-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65293-015-01 [65293001501]

Orbactiv INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA206334
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-09-01
• Marketing End Date: 2021-06-30

NDC 65293-015-03 [65293001503]

Orbactiv INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA206334
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-09-01
• Marketing End Date: 2021-06-30
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-11

Drug Details

Active Ingredients

Ingredient	Strength
ORITAVANCIN	400 mg/1

OpenFDA Data

• SPL SET ID: 085d6d1a-21c2-11e4-8c21-0800200c9a66
• Manufacturer:
  • The Medicines Company
• UNII:
  • PUG62FRZ2E
• RxNorm Concept Unique ID - RxCUI:
  • 1547620
  • 1547615
• UPC Code:
  • 0365293015019

Pharmacological Class

• Lipoglycopeptide Antibacterial [EPC]
• Lipoglycopeptides [EXT]
• Cytochrome P450 2C19 Inhibitors [MoA]
• Cytochrome P450 2C9 Inhibitors [MoA]
• Cytochrome P450 3A4 Inducers [MoA]
• Cytochrome P450 2D6 Inducers [MoA]

NDC Crossover Matching brand name "Orbactiv" or generic name "Oritavancin"

NDC	Brand Name	Generic Name
65293-015	Orbactiv	oritavancin
70842-140	Orbactiv	oritavancin