kimyrsa

Generic: oritavancin diphosphate

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

Drug Facts

Product Profile

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

oritavancin diphosphate 1200 mg/40mL

Manufacturer
Melinta Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70842-225
Product ID 70842-225_25ae2ae5-afce-4475-bf3c-45323e93a952
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214155
Listing Expiration 2026-12-31
Marketing Start 2021-03-23

Pharmacologic Class

Classes
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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70842225
Hyphenated Format 70842-225

Supplemental Identifiers

RxCUI
2532361 2532366
UPC
0370842225016
UNII
VL1P93MKZN

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 kimyrsa (source: ndc)
Generic Name oritavancin diphosphate (source: ndc)
Application Number NDA214155 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1200 mg/40mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (70842-225-01) / 40 mL in 1 VIAL
source: ndc

Packages (1)

70842-225-01 1 VIAL in 1 CARTON (70842-225-01) / 40 mL in 1 VIAL

Ingredients (1)

oritavancin diphosphate (1200 mg/40mL)

Linked Drug Pages (1)

Kimyrsa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "25ae2ae5-afce-4475-bf3c-45323e93a952", "openfda": {"upc": ["0370842225016"], "unii": ["VL1P93MKZN"], "rxcui": ["2532361", "2532366"], "spl_set_id": ["5e755c40-6e73-4572-b474-4d8a131693d1"], "manufacturer_name": ["Melinta Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (70842-225-01)  / 40 mL in 1 VIAL", "package_ndc": "70842-225-01", "marketing_start_date": "20210323"}], "brand_name": "Kimyrsa", "product_id": "70842-225_25ae2ae5-afce-4475-bf3c-45323e93a952", "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": "70842-225", "generic_name": "oritavancin diphosphate", "labeler_name": "Melinta Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Kimyrsa", "active_ingredients": [{"name": "ORITAVANCIN DIPHOSPHATE", "strength": "1200 mg/40mL"}], "application_number": "NDA214155", "marketing_category": "NDA", "marketing_start_date": "20210323", "listing_expiration_date": "20261231"}