linezolid

Generic: linezolid

Labeler: piramal critical care inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name linezolid
Generic Name linezolid
Labeler piramal critical care inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

linezolid 600 mg/300mL

Manufacturer
Piramal Critical Care Inc

Identifiers & Regulatory

Product NDC 66794-219
Product ID 66794-219_3f9d8cdd-0149-bcf4-e063-6394a90a01ca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207001
Listing Expiration 2026-12-31
Marketing Start 2024-03-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66794219
Hyphenated Format 66794-219

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 ANDA207001 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 600 mg/300mL
source: ndc
Packaging
  • 10 BAG in 1 CARTON (66794-219-43) / 300 mL in 1 BAG (66794-219-63)
source: ndc

Packages (1)

66794-219-43 10 BAG in 1 CARTON (66794-219-43) / 300 mL in 1 BAG (66794-219-63)

Ingredients (1)

linezolid (600 mg/300mL)

Linked Drug Pages (1)

Linezolid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3f9d8cdd-0149-bcf4-e063-6394a90a01ca", "openfda": {"nui": ["N0000175495", "M0361132"], "unii": ["ISQ9I6J12J"], "rxcui": ["1662285"], "spl_set_id": ["95b8fd63-d018-8062-e053-2995a90ab96d"], "pharm_class_cs": ["Oxazolidinones [CS]"], "pharm_class_epc": ["Oxazolidinone Antibacterial [EPC]"], "manufacturer_name": ["Piramal Critical Care Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BAG in 1 CARTON (66794-219-43)  / 300 mL in 1 BAG (66794-219-63)", "package_ndc": "66794-219-43", "marketing_start_date": "20240308"}], "brand_name": "Linezolid", "product_id": "66794-219_3f9d8cdd-0149-bcf4-e063-6394a90a01ca", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Oxazolidinone Antibacterial [EPC]", "Oxazolidinones [CS]"], "product_ndc": "66794-219", "generic_name": "Linezolid", "labeler_name": "Piramal Critical Care Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Linezolid", "active_ingredients": [{"name": "LINEZOLID", "strength": "600 mg/300mL"}], "application_number": "ANDA207001", "marketing_category": "ANDA", "marketing_start_date": "20240308", "listing_expiration_date": "20261231"}