zevtera

Generic: ceftobiprole medocaril sodium

Labeler: la jolla pharmaceutical company
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zevtera
Generic Name ceftobiprole medocaril sodium
Labeler la jolla pharmaceutical company
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ceftobiprole medocaril sodium 667 mg/1

Manufacturer
La Jolla Pharmaceutical Company

Identifiers & Regulatory

Product NDC 68547-578
Product ID 68547-578_b1d1d7ef-5f90-4e2e-b4cf-494815d8647c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA218275
Listing Expiration 2026-12-31
Marketing Start 2025-04-01

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs] organic anion transporting polypeptide 1b1 inhibitors [moa] organic anion transporting polypeptide 1b3 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68547578
Hyphenated Format 68547-578

Supplemental Identifiers

RxCUI
2703561 2703567
UNII
N99027V28J

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 zevtera (source: ndc)
Generic Name ceftobiprole medocaril sodium (source: ndc)
Application Number NDA218275 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 667 mg/1
source: ndc
Packaging
  • 10 VIAL, GLASS in 1 BOX (68547-578-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (68547-578-01)
source: ndc

Packages (1)

68547-578-10 10 VIAL, GLASS in 1 BOX (68547-578-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (68547-578-01)

Ingredients (1)

ceftobiprole medocaril sodium (667 mg/1)

Linked Drug Pages (1)

ZEVTERA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "b1d1d7ef-5f90-4e2e-b4cf-494815d8647c", "openfda": {"unii": ["N99027V28J"], "rxcui": ["2703561", "2703567"], "spl_set_id": ["2bd685df-7dc6-78a6-e063-6294a90a580b"], "manufacturer_name": ["La Jolla Pharmaceutical Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, GLASS in 1 BOX (68547-578-10)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (68547-578-01)", "package_ndc": "68547-578-10", "marketing_start_date": "20250401"}], "brand_name": "ZEVTERA", "product_id": "68547-578_b1d1d7ef-5f90-4e2e-b4cf-494815d8647c", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]", "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]"], "product_ndc": "68547-578", "generic_name": "ceftobiprole medocaril sodium", "labeler_name": "La Jolla Pharmaceutical Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZEVTERA", "active_ingredients": [{"name": "CEFTOBIPROLE MEDOCARIL SODIUM", "strength": "667 mg/1"}], "application_number": "NDA218275", "marketing_category": "NDA", "marketing_start_date": "20250401", "listing_expiration_date": "20261231"}