linezolid

Generic: linezolid

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name linezolid
Generic Name linezolid
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

linezolid 600 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6553
Product ID 0904-6553_a9f1f648-96d9-4994-a0cf-7f3ff4da1c19
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205517
Listing Expiration 2026-12-31
Marketing Start 2015-12-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09046553
Hyphenated Format 0904-6553

Supplemental Identifiers

RxCUI
311347
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 ANDA205517 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (0904-6553-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6553-04 30 BLISTER PACK in 1 CARTON (0904-6553-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": "a9f1f648-96d9-4994-a0cf-7f3ff4da1c19", "openfda": {"nui": ["N0000175495", "M0361132"], "unii": ["ISQ9I6J12J"], "rxcui": ["311347"], "spl_set_id": ["bef116a8-427d-4855-86de-0017e01430b0"], "pharm_class_cs": ["Oxazolidinones [CS]"], "pharm_class_epc": ["Oxazolidinone Antibacterial [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0904-6553-04)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6553-04", "marketing_start_date": "20151221"}], "brand_name": "Linezolid", "product_id": "0904-6553_a9f1f648-96d9-4994-a0cf-7f3ff4da1c19", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Oxazolidinone Antibacterial [EPC]", "Oxazolidinones [CS]"], "product_ndc": "0904-6553", "generic_name": "Linezolid", "labeler_name": "Major Pharmaceuticals", "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": "20151221", "listing_expiration_date": "20261231"}