linezolid

Generic: linezolid

Labeler: hp halden pharma as
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name linezolid
Generic Name linezolid
Labeler hp halden pharma as
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

linezolid 2 mg/mL

Manufacturer
Hp Halden Pharma AS

Identifiers & Regulatory

Product NDC 66298-7131
Product ID 66298-7131_1d77a459-7013-fb55-e063-6294a90a0dc1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204764
Listing Expiration 2026-12-31
Marketing Start 2017-07-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 662987131
Hyphenated Format 66298-7131

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 ANDA204764 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 300 mL in 1 BAG (66298-7131-3)
source: ndc

Packages (1)

66298-7131-3 300 mL in 1 BAG (66298-7131-3)

Ingredients (1)

linezolid (2 mg/mL)

Linked Drug Pages (1)

Linezolid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "1d77a459-7013-fb55-e063-6294a90a0dc1", "openfda": {"nui": ["N0000175495", "M0361132"], "unii": ["ISQ9I6J12J"], "rxcui": ["1662285"], "spl_set_id": ["217f3ee2-2534-4c32-8e9d-09b6d65df4af"], "pharm_class_cs": ["Oxazolidinones [CS]"], "pharm_class_epc": ["Oxazolidinone Antibacterial [EPC]"], "manufacturer_name": ["Hp Halden Pharma AS"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "300 mL in 1 BAG (66298-7131-3)", "package_ndc": "66298-7131-3", "marketing_start_date": "20170727"}], "brand_name": "Linezolid", "product_id": "66298-7131_1d77a459-7013-fb55-e063-6294a90a0dc1", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Oxazolidinone Antibacterial [EPC]", "Oxazolidinones [CS]"], "product_ndc": "66298-7131", "generic_name": "LINEZOLID", "labeler_name": "Hp Halden Pharma AS", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Linezolid", "active_ingredients": [{"name": "LINEZOLID", "strength": "2 mg/mL"}], "application_number": "ANDA204764", "marketing_category": "ANDA", "marketing_start_date": "20170727", "listing_expiration_date": "20261231"}