zerbaxa

Generic: ceftolozane and tazobactam

Labeler: merck sharp & dohme llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zerbaxa
Generic Name ceftolozane and tazobactam
Labeler merck sharp & dohme llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ceftolozane sulfate 1 g/10mL, tazobactam sodium .5 g/10mL

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 67919-030
Product ID 67919-030_22bf0411-3002-43cd-a13f-1a18b519e0ae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA206829
Listing Expiration 2026-12-31
Marketing Start 2014-12-19

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs] beta lactamase inhibitor [epc] beta lactamase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67919030
Hyphenated Format 67919-030

Supplemental Identifiers

RxCUI
1597615 1597620
UNII
7R247U84HY UXA545ABTT

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 zerbaxa (source: ndc)
Generic Name ceftolozane and tazobactam (source: ndc)
Application Number NDA206829 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/10mL
  • .5 g/10mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (67919-030-01) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

67919-030-01 10 VIAL, SINGLE-DOSE in 1 CARTON (67919-030-01) / 10 mL in 1 VIAL, SINGLE-DOSE

Ingredients (2)

ceftolozane sulfate (1 g/10mL) tazobactam sodium (.5 g/10mL)

Linked Drug Pages (1)

ZERBAXA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "22bf0411-3002-43cd-a13f-1a18b519e0ae", "openfda": {"unii": ["7R247U84HY", "UXA545ABTT"], "rxcui": ["1597615", "1597620"], "spl_set_id": ["70ac1d90-eff3-4f0b-9f46-5846c571b32f"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (67919-030-01)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "67919-030-01", "marketing_start_date": "20141219"}], "brand_name": "ZERBAXA", "product_id": "67919-030_22bf0411-3002-43cd-a13f-1a18b519e0ae", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "67919-030", "generic_name": "ceftolozane and tazobactam", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZERBAXA", "active_ingredients": [{"name": "CEFTOLOZANE SULFATE", "strength": "1 g/10mL"}, {"name": "TAZOBACTAM SODIUM", "strength": ".5 g/10mL"}], "application_number": "NDA206829", "marketing_category": "NDA", "marketing_start_date": "20141219", "listing_expiration_date": "20261231"}