linezolid

Generic: linezolid

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name linezolid
Generic Name linezolid
Labeler macleods pharmaceuticals limited
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

linezolid 600 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-352
Product ID 33342-352_90dd8c13-c428-4472-91e5-5b1fcdc4fce3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210378
Listing Expiration 2026-12-31
Marketing Start 2024-10-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342352
Hyphenated Format 33342-352

Supplemental Identifiers

RxCUI
311347
UPC
0333342352118 0333342352323
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 ANDA210378 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (33342-352-11)
  • 5 BLISTER PACK in 1 CARTON (33342-352-31) / 10 TABLET, COATED in 1 BLISTER PACK
  • 20 TABLET, COATED in 1 BOTTLE (33342-352-32)
source: ndc

Packages (3)

33342-352-11 100 TABLET, COATED in 1 BOTTLE (33342-352-11) 33342-352-31 5 BLISTER PACK in 1 CARTON (33342-352-31) / 10 TABLET, COATED in 1 BLISTER PACK 33342-352-32 20 TABLET, COATED in 1 BOTTLE (33342-352-32)

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": "90dd8c13-c428-4472-91e5-5b1fcdc4fce3", "openfda": {"nui": ["N0000175495", "M0361132"], "upc": ["0333342352118", "0333342352323"], "unii": ["ISQ9I6J12J"], "rxcui": ["311347"], "spl_set_id": ["90dd8c13-c428-4472-91e5-5b1fcdc4fce3"], "pharm_class_cs": ["Oxazolidinones [CS]"], "pharm_class_epc": ["Oxazolidinone Antibacterial [EPC]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (33342-352-11)", "package_ndc": "33342-352-11", "marketing_start_date": "20241010"}, {"sample": false, "description": "5 BLISTER PACK in 1 CARTON (33342-352-31)  / 10 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "33342-352-31", "marketing_start_date": "20241010"}, {"sample": false, "description": "20 TABLET, COATED in 1 BOTTLE (33342-352-32)", "package_ndc": "33342-352-32", "marketing_start_date": "20241010"}], "brand_name": "Linezolid", "product_id": "33342-352_90dd8c13-c428-4472-91e5-5b1fcdc4fce3", "dosage_form": "TABLET, COATED", "pharm_class": ["Oxazolidinone Antibacterial [EPC]", "Oxazolidinones [CS]"], "product_ndc": "33342-352", "generic_name": "Linezolid", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Linezolid", "active_ingredients": [{"name": "LINEZOLID", "strength": "600 mg/1"}], "application_number": "ANDA210378", "marketing_category": "ANDA", "marketing_start_date": "20241010", "listing_expiration_date": "20261231"}