zyvox

Generic: linezolid

Labeler: hp halden pharma as
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zyvox
Generic Name linezolid
Labeler hp halden pharma as
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

linezolid 200 mg/100mL

Manufacturer
Hp Halden Pharma AS

Identifiers & Regulatory

Product NDC 66298-5137
Product ID 66298-5137_1988348c-3b04-2b38-e063-6394a90ada27
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021131
Listing Expiration 2026-12-31
Marketing Start 2018-06-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 662985137
Hyphenated Format 66298-5137

Supplemental Identifiers

RxCUI
1662278 1662280
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 NDA021131 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/100mL
source: ndc
Packaging
  • 100 mL in 1 BAG (66298-5137-1)
source: ndc

Packages (1)

66298-5137-1 100 mL in 1 BAG (66298-5137-1)

Ingredients (1)

linezolid (200 mg/100mL)

Linked Drug Pages (1)

Zyvox ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "1988348c-3b04-2b38-e063-6394a90ada27", "openfda": {"nui": ["N0000175495", "M0361132"], "unii": ["ISQ9I6J12J"], "rxcui": ["1662278", "1662280"], "spl_set_id": ["ce57225b-4580-442b-8c48-8045297cbb50"], "pharm_class_cs": ["Oxazolidinones [CS]"], "pharm_class_epc": ["Oxazolidinone Antibacterial [EPC]"], "manufacturer_name": ["Hp Halden Pharma AS"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BAG (66298-5137-1)", "package_ndc": "66298-5137-1", "marketing_start_date": "20180604"}], "brand_name": "Zyvox", "product_id": "66298-5137_1988348c-3b04-2b38-e063-6394a90ada27", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Oxazolidinone Antibacterial [EPC]", "Oxazolidinones [CS]"], "product_ndc": "66298-5137", "generic_name": "LINEZOLID", "labeler_name": "Hp Halden Pharma AS", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zyvox", "active_ingredients": [{"name": "LINEZOLID", "strength": "200 mg/100mL"}], "application_number": "NDA021131", "marketing_category": "NDA", "marketing_start_date": "20180604", "listing_expiration_date": "20261231"}