linezolid

Generic: linezolid

Labeler: sportpharm, inc. dba sportpharm
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name linezolid
Generic Name linezolid
Labeler sportpharm, inc. dba sportpharm
Dosage Form TABLET
Routes
ORAL
Active Ingredients

linezolid 600 mg/1

Manufacturer
Sportpharm, Inc. dba Sportpharm

Identifiers & Regulatory

Product NDC 85766-075
Product ID 85766-075_40c87527-ecda-4f14-e063-6394a90a17fe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078845
Listing Expiration 2026-12-31
Marketing Start 2023-11-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85766075
Hyphenated Format 85766-075

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 ANDA078845 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 20 TABLET in 1 BOTTLE (85766-075-20)
  • 30 TABLET in 1 BOTTLE (85766-075-30)
source: ndc

Packages (2)

85766-075-20 20 TABLET in 1 BOTTLE (85766-075-20) 85766-075-30 30 TABLET in 1 BOTTLE (85766-075-30)

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": "40c87527-ecda-4f14-e063-6394a90a17fe", "openfda": {"nui": ["N0000175495", "M0361132"], "unii": ["ISQ9I6J12J"], "rxcui": ["311347"], "spl_set_id": ["561abed1-c0f9-40ee-98a8-7c710bcde822"], "pharm_class_cs": ["Oxazolidinones [CS]"], "pharm_class_epc": ["Oxazolidinone Antibacterial [EPC]"], "manufacturer_name": ["Sportpharm, Inc. dba Sportpharm"]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET in 1 BOTTLE (85766-075-20)", "package_ndc": "85766-075-20", "marketing_start_date": "20251010"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (85766-075-30)", "package_ndc": "85766-075-30", "marketing_start_date": "20251010"}], "brand_name": "Linezolid", "product_id": "85766-075_40c87527-ecda-4f14-e063-6394a90a17fe", "dosage_form": "TABLET", "pharm_class": ["Oxazolidinone Antibacterial [EPC]", "Oxazolidinones [CS]"], "product_ndc": "85766-075", "generic_name": "Linezolid", "labeler_name": "Sportpharm, Inc. dba Sportpharm", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Linezolid", "active_ingredients": [{"name": "LINEZOLID", "strength": "600 mg/1"}], "application_number": "ANDA078845", "marketing_category": "ANDA", "marketing_start_date": "20231120", "listing_expiration_date": "20261231"}