NDC 70842-140

Orbactiv

Oritavancin

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

• Product ID: 70842-140_015e07ad-5685-4bcb-8d0a-157a7ceb5234
• NDC: 70842-140
• 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 Category: NDA / NDA
• Application Number: NDA206334
• Labeler Name: Melinta Therapeutics, Inc.
• 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
• Listing Certified Through: 2019-12-31

Packaging

NDC 70842-140-03

3 VIAL, GLASS in 1 CARTON (70842-140-03) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (70842-140-01)

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

NDC SPL Data Element Entries

NDC 70842-140-03 [70842014003]

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

NDC 70842-140-01 [70842014001]

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

Drug Details

Active Ingredients

Ingredient	Strength
ORITAVANCIN	400 mg/1

OpenFDA Data

• SPL SET ID: ff09a726-9f9b-4e30-b509-396781293220
• Manufacturer:
  • Melinta Therapeutics, Inc.
• UNII:
  • PUG62FRZ2E
• RxNorm Concept Unique ID - RxCUI:
  • 1547620
  • 1547615

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