zyvox

Generic: linezolid

Labeler: pharmacia & upjohn company llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zyvox
Generic Name linezolid
Labeler pharmacia & upjohn company llc
Dosage Form GRANULE, FOR SUSPENSION
Routes
ORAL
Active Ingredients

linezolid 100 mg/5mL

Manufacturer
Pharmacia & Upjohn Company LLC

Identifiers & Regulatory

Product NDC 0009-5136
Product ID 0009-5136_c038c5e0-0b25-4a00-82d9-b7ff930fe948
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021132
Listing Expiration 2027-12-31
Marketing Start 2000-04-18

Pharmacologic Class

Established (EPC)
oxazolidinone antibacterial [epc]
Chemical Structure
oxazolidinones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00095136
Hyphenated Format 0009-5136

Supplemental Identifiers

RxCUI
262091 311345 311347 581614 1662278 1662280 1662285 1662286
UPC
0300095138023
UNII
ISQ9I6J12J
NUI
N0000175495 M0361132

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 zyvox (source: ndc)
Generic Name linezolid (source: ndc)
Application Number NDA021132 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 150 mL in 1 BOTTLE (0009-5136-01)
  • 150 mL in 1 BOTTLE (0009-5136-04)
source: ndc

Packages (2)

0009-5136-01 150 mL in 1 BOTTLE (0009-5136-01) 0009-5136-04 150 mL in 1 BOTTLE (0009-5136-04)

Ingredients (1)

linezolid (100 mg/5mL)

Linked Drug Pages (1)

Zyvox ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c038c5e0-0b25-4a00-82d9-b7ff930fe948", "openfda": {"nui": ["N0000175495", "M0361132"], "upc": ["0300095138023"], "unii": ["ISQ9I6J12J"], "rxcui": ["262091", "311345", "311347", "581614", "1662278", "1662280", "1662285", "1662286"], "spl_set_id": ["6e70e63b-bfd5-478d-a8ee-8ba22c9efabd"], "pharm_class_cs": ["Oxazolidinones [CS]"], "pharm_class_epc": ["Oxazolidinone Antibacterial [EPC]"], "manufacturer_name": ["Pharmacia & Upjohn Company LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "150 mL in 1 BOTTLE (0009-5136-01)", "package_ndc": "0009-5136-01", "marketing_start_date": "20000418"}, {"sample": false, "description": "150 mL in 1 BOTTLE (0009-5136-04)", "package_ndc": "0009-5136-04", "marketing_start_date": "20230327"}], "brand_name": "Zyvox", "product_id": "0009-5136_c038c5e0-0b25-4a00-82d9-b7ff930fe948", "dosage_form": "GRANULE, FOR SUSPENSION", "pharm_class": ["Oxazolidinone Antibacterial [EPC]", "Oxazolidinones [CS]"], "product_ndc": "0009-5136", "generic_name": "linezolid", "labeler_name": "Pharmacia & Upjohn Company LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zyvox", "active_ingredients": [{"name": "LINEZOLID", "strength": "100 mg/5mL"}], "application_number": "NDA021132", "marketing_category": "NDA", "marketing_start_date": "20000418", "listing_expiration_date": "20271231"}