linezolid

Generic: linezolid

Labeler: hospira, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name linezolid
Generic Name linezolid
Labeler hospira, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

linezolid 2 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-4883
Product ID 0409-4883_2b490a64-b68f-43a8-b1d9-4cdbedce2f20
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA206473
Listing Expiration 2026-12-31
Marketing Start 2015-06-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04094883
Hyphenated Format 0409-4883

Supplemental Identifiers

RxCUI
1662285
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 linezolid (source: ndc)
Generic Name linezolid (source: ndc)
Application Number NDA206473 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 10 POUCH in 1 CASE (0409-4883-01) / 1 BAG in 1 POUCH / 300 mL in 1 BAG (0409-4883-11)
  • 10 POUCH in 1 CASE (0409-4883-10) / 1 BAG in 1 POUCH / 300 mL in 1 BAG (0409-4883-03)
source: ndc

Packages (2)

0409-4883-01 10 POUCH in 1 CASE (0409-4883-01) / 1 BAG in 1 POUCH / 300 mL in 1 BAG (0409-4883-11) 0409-4883-10 10 POUCH in 1 CASE (0409-4883-10) / 1 BAG in 1 POUCH / 300 mL in 1 BAG (0409-4883-03)

Ingredients (1)

linezolid (2 mg/mL)

Linked Drug Pages (1)

Linezolid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2b490a64-b68f-43a8-b1d9-4cdbedce2f20", "openfda": {"nui": ["N0000175495", "M0361132"], "unii": ["ISQ9I6J12J"], "rxcui": ["1662285"], "spl_set_id": ["c401f1a8-cc37-461b-bfef-f2e156629bf8"], "pharm_class_cs": ["Oxazolidinones [CS]"], "pharm_class_epc": ["Oxazolidinone Antibacterial [EPC]"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 POUCH in 1 CASE (0409-4883-01)  / 1 BAG in 1 POUCH / 300 mL in 1 BAG (0409-4883-11)", "package_ndc": "0409-4883-01", "marketing_start_date": "20150618"}, {"sample": false, "description": "10 POUCH in 1 CASE (0409-4883-10)  / 1 BAG in 1 POUCH / 300 mL in 1 BAG (0409-4883-03)", "package_ndc": "0409-4883-10", "marketing_start_date": "20230619"}], "brand_name": "Linezolid", "product_id": "0409-4883_2b490a64-b68f-43a8-b1d9-4cdbedce2f20", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Oxazolidinone Antibacterial [EPC]", "Oxazolidinones [CS]"], "product_ndc": "0409-4883", "generic_name": "LINEZOLID", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Linezolid", "active_ingredients": [{"name": "LINEZOLID", "strength": "2 mg/mL"}], "application_number": "NDA206473", "marketing_category": "NDA", "marketing_start_date": "20150618", "listing_expiration_date": "20261231"}