linezolid

Generic: linezolid

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

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

linezolid 600 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59762-1307
Product ID 59762-1307_4de67c3c-cad0-4da2-8eab-da7a184135bc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021130
Marketing Start 2015-10-12
Marketing End 2026-08-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 597621307
Hyphenated Format 59762-1307

Supplemental Identifiers

RxCUI
311347
UPC
0359762130716
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 NDA021130 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (59762-1307-1)
  • 20 BLISTER PACK in 1 BOX, UNIT-DOSE (59762-1307-2) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

59762-1307-1 20 TABLET, FILM COATED in 1 BOTTLE (59762-1307-1) 59762-1307-2 20 BLISTER PACK in 1 BOX, UNIT-DOSE (59762-1307-2) / 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": "4de67c3c-cad0-4da2-8eab-da7a184135bc", "openfda": {"nui": ["N0000175495", "M0361132"], "upc": ["0359762130716"], "unii": ["ISQ9I6J12J"], "rxcui": ["311347"], "spl_set_id": ["374af2a7-d994-40bd-a86a-cd9038d0b72c"], "pharm_class_cs": ["Oxazolidinones [CS]"], "pharm_class_epc": ["Oxazolidinone Antibacterial [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (59762-1307-1)", "package_ndc": "59762-1307-1", "marketing_end_date": "20260430", "marketing_start_date": "20151012"}, {"sample": false, "description": "20 BLISTER PACK in 1 BOX, UNIT-DOSE (59762-1307-2)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "59762-1307-2", "marketing_end_date": "20260831", "marketing_start_date": "20151012"}], "brand_name": "Linezolid", "product_id": "59762-1307_4de67c3c-cad0-4da2-8eab-da7a184135bc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Oxazolidinone Antibacterial [EPC]", "Oxazolidinones [CS]"], "product_ndc": "59762-1307", "generic_name": "linezolid", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Linezolid", "active_ingredients": [{"name": "LINEZOLID", "strength": "600 mg/1"}], "application_number": "NDA021130", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_end_date": "20260831", "marketing_start_date": "20151012"}