linezolid

Generic: linezolid

Labeler: caplin steriles limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name linezolid
Generic Name linezolid
Labeler caplin steriles limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

linezolid 600 mg/300mL

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-181
Product ID 65145-181_2220c753-e0e8-4797-bce2-34b3c63bd631
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219558
Listing Expiration 2026-12-31
Marketing Start 2025-12-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65145181
Hyphenated Format 65145-181

Supplemental Identifiers

RxCUI
1662285
UPC
0365145181015
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 ANDA219558 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 600 mg/300mL
source: ndc
Packaging
  • 10 POUCH in 1 CASE (65145-181-10) / 1 BAG in 1 POUCH (65145-181-01) / 300 mL in 1 BAG
source: ndc

Packages (1)

65145-181-10 10 POUCH in 1 CASE (65145-181-10) / 1 BAG in 1 POUCH (65145-181-01) / 300 mL in 1 BAG

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": "2220c753-e0e8-4797-bce2-34b3c63bd631", "openfda": {"nui": ["N0000175495", "M0361132"], "upc": ["0365145181015"], "unii": ["ISQ9I6J12J"], "rxcui": ["1662285"], "spl_set_id": ["2220c753-e0e8-4797-bce2-34b3c63bd631"], "pharm_class_cs": ["Oxazolidinones [CS]"], "pharm_class_epc": ["Oxazolidinone Antibacterial [EPC]"], "manufacturer_name": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 POUCH in 1 CASE (65145-181-10)  / 1 BAG in 1 POUCH (65145-181-01)  / 300 mL in 1 BAG", "package_ndc": "65145-181-10", "marketing_start_date": "20251223"}], "brand_name": "Linezolid", "product_id": "65145-181_2220c753-e0e8-4797-bce2-34b3c63bd631", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Oxazolidinone Antibacterial [EPC]", "Oxazolidinones [CS]"], "product_ndc": "65145-181", "generic_name": "linezolid", "labeler_name": "Caplin Steriles Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Linezolid", "active_ingredients": [{"name": "LINEZOLID", "strength": "600 mg/300mL"}], "application_number": "ANDA219558", "marketing_category": "ANDA", "marketing_start_date": "20251223", "listing_expiration_date": "20261231"}