orbactiv

Generic: oritavancin

Labeler: melinta therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name orbactiv
Generic Name oritavancin
Labeler melinta therapeutics, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

oritavancin 400 mg/1

Manufacturer
Melinta Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70842-140
Product ID 70842-140_4c7649f3-4d38-47e2-aa0d-2ed606bb930a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA206334
Listing Expiration 2026-12-31
Marketing Start 2014-09-01

Pharmacologic Class

Established (EPC)
lipoglycopeptide antibacterial [epc]
Mechanism of Action
cytochrome p450 2c19 inhibitors [moa] cytochrome p450 2c9 inhibitors [moa] cytochrome p450 3a4 inducers [moa] cytochrome p450 2d6 inducers [moa]
Chemical Structure
lipoglycopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70842140
Hyphenated Format 70842-140

Supplemental Identifiers

RxCUI
1547615 1547620
UNII
PUG62FRZ2E
NUI
N0000191281 M000640741 N0000182140 N0000185504 N0000185506 N0000191267

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name orbactiv (source: ndc)
Generic Name oritavancin (source: ndc)
Application Number NDA206334 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 3 VIAL, GLASS in 1 CARTON (70842-140-03) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (70842-140-01)
source: ndc

Packages (1)

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)

Ingredients (1)

oritavancin (400 mg/1)

Linked Drug Pages (1)

Orbactiv ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "4c7649f3-4d38-47e2-aa0d-2ed606bb930a", "openfda": {"nui": ["N0000191281", "M000640741", "N0000182140", "N0000185504", "N0000185506", "N0000191267"], "unii": ["PUG62FRZ2E"], "rxcui": ["1547615", "1547620"], "spl_set_id": ["ff09a726-9f9b-4e30-b509-396781293220"], "pharm_class_cs": ["Lipoglycopeptides [CS]"], "pharm_class_epc": ["Lipoglycopeptide Antibacterial [EPC]"], "pharm_class_moa": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Cytochrome P450 2D6 Inducers [MoA]"], "manufacturer_name": ["Melinta Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 VIAL, GLASS in 1 CARTON (70842-140-03)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (70842-140-01)", "package_ndc": "70842-140-03", "marketing_start_date": "20140901"}], "brand_name": "Orbactiv", "product_id": "70842-140_4c7649f3-4d38-47e2-aa0d-2ed606bb930a", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 2D6 Inducers [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Lipoglycopeptide Antibacterial [EPC]", "Lipoglycopeptides [CS]"], "product_ndc": "70842-140", "generic_name": "oritavancin", "labeler_name": "Melinta Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Orbactiv", "active_ingredients": [{"name": "ORITAVANCIN", "strength": "400 mg/1"}], "application_number": "NDA206334", "marketing_category": "NDA", "marketing_start_date": "20140901", "listing_expiration_date": "20261231"}