linezolid

Generic: linezolid

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name linezolid
Generic Name linezolid
Labeler sandoz inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

linezolid 200 mg/100mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-3431
Product ID 0781-3431_731258b6-fb75-4612-b7e6-cfec8f312aaf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200904
Listing Expiration 2026-12-31
Marketing Start 2016-06-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07813431
Hyphenated Format 0781-3431

Supplemental Identifiers

RxCUI
1662278 1662285
UPC
0307813431466
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 ANDA200904 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/100mL
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 Injection Linezolid intravenous injection is available in single-dose, ready-to-use flexible plastic infusion bags in a foil laminate overwrap. The infusion bags and ports are not made with natural rubber latex. The infusion bags are available in the following package sizes: NDC 0781-3431-46 100 mL bag (200 mg linezolid) NDC 0781-3431-95 pack of 10 x 100 mL bags (200 mg linezolid) NDC 0781-3433-46 300 mL bag (600 mg linezolid) NDC 0781-3433-95 pack of 10 x 300 mL bags (600 mg linezolid) 16.4 Storage and Handling Store at 20° to 25°C (68° to 77°F). Protect from light. It is recommended that the infusion bags be kept in the overwrap until ready to use. Protect infusion bags from freezing.
  • Principal Display Panel NDC 0781-3431-46 Linezolid Injection-Switzerland 200 mg/100 mL For Intravenous Use 200mglabelforswitzerland
  • Principal Display Panel NDC 0781-3433-46 Linezolid Injection-Switzerland 600 mg/300 mL For Intravenous Use label
source: label

Packages (0)

No package records.

Ingredients (1)

linezolid (200 mg/100mL)

Linked Drug Pages (1)

Linezolid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "731258b6-fb75-4612-b7e6-cfec8f312aaf", "openfda": {"nui": ["N0000175495", "M0361132"], "upc": ["0307813431466"], "unii": ["ISQ9I6J12J"], "rxcui": ["1662278", "1662285"], "spl_set_id": ["a287cdf4-47a8-459f-8890-86181af5e836"], "pharm_class_cs": ["Oxazolidinones [CS]"], "pharm_class_epc": ["Oxazolidinone Antibacterial [EPC]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Linezolid", "product_id": "0781-3431_731258b6-fb75-4612-b7e6-cfec8f312aaf", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Oxazolidinone Antibacterial [EPC]", "Oxazolidinones [CS]"], "product_ndc": "0781-3431", "generic_name": "Linezolid", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Linezolid", "active_ingredients": [{"name": "LINEZOLID", "strength": "200 mg/100mL"}], "application_number": "ANDA200904", "marketing_category": "ANDA", "marketing_start_date": "20160615", "listing_expiration_date": "20261231"}