linezolid

Generic: linezolid

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name linezolid
Generic Name linezolid
Labeler camber pharmaceuticals, inc.
Dosage Form GRANULE, FOR SUSPENSION
Routes
ORAL
Active Ingredients

linezolid 100 mg/5mL

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-865
Product ID 31722-865_05657697-e108-9eaf-e063-6294a90a5d97
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211813
Listing Expiration 2026-12-31
Marketing Start 2022-10-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722865
Hyphenated Format 31722-865

Supplemental Identifiers

RxCUI
311345
UPC
0331722865258
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 ANDA211813 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (31722-865-25) / 150 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

31722-865-25 1 BOTTLE, GLASS in 1 CARTON (31722-865-25) / 150 mL in 1 BOTTLE, GLASS

Ingredients (1)

linezolid (100 mg/5mL)

Linked Drug Pages (1)

Linezolid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "05657697-e108-9eaf-e063-6294a90a5d97", "openfda": {"nui": ["N0000175495", "M0361132"], "upc": ["0331722865258"], "unii": ["ISQ9I6J12J"], "rxcui": ["311345"], "spl_set_id": ["a89a37ec-a736-464b-a83a-84bef6ccd702"], "pharm_class_cs": ["Oxazolidinones [CS]"], "pharm_class_epc": ["Oxazolidinone Antibacterial [EPC]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (31722-865-25)  / 150 mL in 1 BOTTLE, GLASS", "package_ndc": "31722-865-25", "marketing_start_date": "20221031"}], "brand_name": "Linezolid", "product_id": "31722-865_05657697-e108-9eaf-e063-6294a90a5d97", "dosage_form": "GRANULE, FOR SUSPENSION", "pharm_class": ["Oxazolidinone Antibacterial [EPC]", "Oxazolidinones [CS]"], "product_ndc": "31722-865", "generic_name": "Linezolid", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Linezolid", "active_ingredients": [{"name": "LINEZOLID", "strength": "100 mg/5mL"}], "application_number": "ANDA211813", "marketing_category": "ANDA", "marketing_start_date": "20221031", "listing_expiration_date": "20261231"}