linezolid

Generic: linezolid

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name linezolid
Generic Name linezolid
Labeler hikma pharmaceuticals usa inc.
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

linezolid 100 mg/5mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0319
Product ID 0054-0319_ea8ff456-80d5-4f40-b397-a25b31a77947
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200068
Listing Expiration 2026-12-31
Marketing Start 2015-06-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540319
Hyphenated Format 0054-0319

Supplemental Identifiers

RxCUI
311345
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 ANDA200068 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 150 mL in 1 BOTTLE (0054-0319-50)
source: ndc

Packages (1)

0054-0319-50 150 mL in 1 BOTTLE (0054-0319-50)

Ingredients (1)

linezolid (100 mg/5mL)

Linked Drug Pages (1)

Linezolid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ea8ff456-80d5-4f40-b397-a25b31a77947", "openfda": {"nui": ["N0000175495", "M0361132"], "unii": ["ISQ9I6J12J"], "rxcui": ["311345"], "spl_set_id": ["16007ca5-7956-4414-af38-406a6623400e"], "pharm_class_cs": ["Oxazolidinones [CS]"], "pharm_class_epc": ["Oxazolidinone Antibacterial [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "150 mL in 1 BOTTLE (0054-0319-50)", "package_ndc": "0054-0319-50", "marketing_start_date": "20150603"}], "brand_name": "Linezolid", "product_id": "0054-0319_ea8ff456-80d5-4f40-b397-a25b31a77947", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Oxazolidinone Antibacterial [EPC]", "Oxazolidinones [CS]"], "product_ndc": "0054-0319", "generic_name": "linezolid", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Linezolid", "active_ingredients": [{"name": "LINEZOLID", "strength": "100 mg/5mL"}], "application_number": "ANDA200068", "marketing_category": "ANDA", "marketing_start_date": "20150603", "listing_expiration_date": "20261231"}