linezolid

Generic: linezolid

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name linezolid
Generic Name linezolid
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

linezolid 600 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-442
Product ID 62135-442_42c9dc2a-45a8-d122-e063-6294a90ac4c5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210702
Listing Expiration 2026-12-31
Marketing Start 2019-04-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135442
Hyphenated Format 62135-442

Supplemental Identifiers

RxCUI
311347
UPC
0362135442200
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 ANDA210702 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 20 TABLET in 1 BOTTLE (62135-442-20)
source: ndc

Packages (1)

62135-442-20 20 TABLET in 1 BOTTLE (62135-442-20)

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": "42c9dc2a-45a8-d122-e063-6294a90ac4c5", "openfda": {"nui": ["N0000175495", "M0361132"], "upc": ["0362135442200"], "unii": ["ISQ9I6J12J"], "rxcui": ["311347"], "spl_set_id": ["9d1b4d0a-0fd9-448b-a28f-51ed05a5a0cf"], "pharm_class_cs": ["Oxazolidinones [CS]"], "pharm_class_epc": ["Oxazolidinone Antibacterial [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET in 1 BOTTLE (62135-442-20)", "package_ndc": "62135-442-20", "marketing_start_date": "20230221"}], "brand_name": "linezolid", "product_id": "62135-442_42c9dc2a-45a8-d122-e063-6294a90ac4c5", "dosage_form": "TABLET", "pharm_class": ["Oxazolidinone Antibacterial [EPC]", "Oxazolidinones [CS]"], "product_ndc": "62135-442", "generic_name": "linezolid", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "linezolid", "active_ingredients": [{"name": "LINEZOLID", "strength": "600 mg/1"}], "application_number": "ANDA210702", "marketing_category": "ANDA", "marketing_start_date": "20190425", "listing_expiration_date": "20261231"}