linezolid

Generic: linezolid

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name linezolid
Generic Name linezolid
Labeler coupler llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

linezolid 600 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1576
Product ID 67046-1576_3dff6e84-a494-5993-e063-6394a90aa8f1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204239
Listing Expiration 2026-12-31
Marketing Start 2025-09-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461576
Hyphenated Format 67046-1576

Supplemental Identifiers

RxCUI
311347
UNII
ISQ9I6J12J
NUI
N0000175495 M0361132

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 ANDA204239 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1576-3)
source: ndc

Packages (1)

67046-1576-3 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1576-3)

Ingredients (1)

linezolid (600 mg/1)

Linked Drug Pages (1)

Linezolid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3dff6e84-a494-5993-e063-6394a90aa8f1", "openfda": {"nui": ["N0000175495", "M0361132"], "unii": ["ISQ9I6J12J"], "rxcui": ["311347"], "spl_set_id": ["3dff6eec-8662-335f-e063-6294a90ab159"], "pharm_class_cs": ["Oxazolidinones [CS]"], "pharm_class_epc": ["Oxazolidinone Antibacterial [EPC]"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1576-3)", "package_ndc": "67046-1576-3", "marketing_start_date": "20250904"}], "brand_name": "Linezolid", "product_id": "67046-1576_3dff6e84-a494-5993-e063-6394a90aa8f1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Oxazolidinone Antibacterial [EPC]", "Oxazolidinones [CS]"], "product_ndc": "67046-1576", "generic_name": "Linezolid", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Linezolid", "active_ingredients": [{"name": "LINEZOLID", "strength": "600 mg/1"}], "application_number": "ANDA204239", "marketing_category": "ANDA", "marketing_start_date": "20250904", "listing_expiration_date": "20261231"}