linezolid

Generic: linezolid

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name linezolid
Generic Name linezolid
Labeler sun pharmaceutical industries, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

linezolid 600 mg/300mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 57664-683
Product ID 57664-683_2e599906-ac35-54ab-e063-6394a90ac605
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207354
Listing Expiration 2026-12-31
Marketing Start 2017-02-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57664683
Hyphenated Format 57664-683

Supplemental Identifiers

RxCUI
1662278 1662285
UPC
0357664683316 0357664682302
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 ANDA207354 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 600 mg/300mL
source: ndc
Packaging
  • 10 BAG in 1 BOX (57664-683-57) / 300 mL in 1 BAG (57664-683-31)
source: ndc

Packages (1)

57664-683-57 10 BAG in 1 BOX (57664-683-57) / 300 mL in 1 BAG (57664-683-31)

Ingredients (1)

linezolid (600 mg/300mL)

Linked Drug Pages (1)

Linezolid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2e599906-ac35-54ab-e063-6394a90ac605", "openfda": {"nui": ["N0000175495", "M0361132"], "upc": ["0357664683316", "0357664682302"], "unii": ["ISQ9I6J12J"], "rxcui": ["1662278", "1662285"], "spl_set_id": ["870c9600-04d5-4b44-a5b5-02252a310f22"], "pharm_class_cs": ["Oxazolidinones [CS]"], "pharm_class_epc": ["Oxazolidinone Antibacterial [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BAG in 1 BOX (57664-683-57)  / 300 mL in 1 BAG (57664-683-31)", "package_ndc": "57664-683-57", "marketing_start_date": "20170201"}], "brand_name": "Linezolid", "product_id": "57664-683_2e599906-ac35-54ab-e063-6394a90ac605", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Oxazolidinone Antibacterial [EPC]", "Oxazolidinones [CS]"], "product_ndc": "57664-683", "generic_name": "linezolid", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Linezolid", "active_ingredients": [{"name": "LINEZOLID", "strength": "600 mg/300mL"}], "application_number": "ANDA207354", "marketing_category": "ANDA", "marketing_start_date": "20170201", "listing_expiration_date": "20261231"}