linezolid

Generic: linezolid

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name linezolid
Generic Name linezolid
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

linezolid 2 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-713
Product ID 63323-713_d151d608-d9c5-4b78-b99b-f0cb53e6c439
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204764
Listing Expiration 2026-12-31
Marketing Start 2015-06-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323713
Hyphenated Format 63323-713

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 ANDA204764 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 10 BAG in 1 CASE (63323-713-13) / 300 mL in 1 BAG (63323-713-03)
source: ndc

Packages (1)

63323-713-13 10 BAG in 1 CASE (63323-713-13) / 300 mL in 1 BAG (63323-713-03)

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": "d151d608-d9c5-4b78-b99b-f0cb53e6c439", "openfda": {"nui": ["N0000175495", "M0361132"], "unii": ["ISQ9I6J12J"], "rxcui": ["1662285"], "spl_set_id": ["cc3e3ea4-50aa-49ee-a8bc-fb48bfc8e014"], "pharm_class_cs": ["Oxazolidinones [CS]"], "pharm_class_epc": ["Oxazolidinone Antibacterial [EPC]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BAG in 1 CASE (63323-713-13)  / 300 mL in 1 BAG (63323-713-03)", "package_ndc": "63323-713-13", "marketing_start_date": "20150622"}], "brand_name": "Linezolid", "product_id": "63323-713_d151d608-d9c5-4b78-b99b-f0cb53e6c439", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Oxazolidinone Antibacterial [EPC]", "Oxazolidinones [CS]"], "product_ndc": "63323-713", "generic_name": "Linezolid", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Linezolid", "active_ingredients": [{"name": "LINEZOLID", "strength": "2 mg/mL"}], "application_number": "ANDA204764", "marketing_category": "ANDA", "marketing_start_date": "20150622", "listing_expiration_date": "20261231"}