linezolid

Generic: linezolid

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name linezolid
Generic Name linezolid
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

linezolid 600 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4034
Product ID 70518-4034_45c15571-71e0-c60a-e063-6294a90a5eef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205517
Listing Expiration 2026-12-31
Marketing Start 2024-05-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184034
Hyphenated Format 70518-4034

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 ANDA205517 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (70518-4034-0)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4034-1)
source: ndc

Packages (2)

70518-4034-0 20 TABLET, FILM COATED in 1 BOTTLE (70518-4034-0) 70518-4034-1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4034-1)

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": "45c15571-71e0-c60a-e063-6294a90a5eef", "openfda": {"nui": ["N0000175495", "M0361132"], "unii": ["ISQ9I6J12J"], "rxcui": ["311347"], "spl_set_id": ["3e0d868d-f419-47e8-a3bc-41ececac468b"], "pharm_class_cs": ["Oxazolidinones [CS]"], "pharm_class_epc": ["Oxazolidinone Antibacterial [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (70518-4034-0)", "package_ndc": "70518-4034-0", "marketing_start_date": "20240508"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4034-1)", "package_ndc": "70518-4034-1", "marketing_start_date": "20251212"}], "brand_name": "Linezolid", "product_id": "70518-4034_45c15571-71e0-c60a-e063-6294a90a5eef", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Oxazolidinone Antibacterial [EPC]", "Oxazolidinones [CS]"], "product_ndc": "70518-4034", "generic_name": "Linezolid", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Linezolid", "active_ingredients": [{"name": "LINEZOLID", "strength": "600 mg/1"}], "application_number": "ANDA205517", "marketing_category": "ANDA", "marketing_start_date": "20240508", "listing_expiration_date": "20261231"}