linezolid

Generic: linezolid

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name linezolid
Generic Name linezolid
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

linezolid 600 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8576
Product ID 63629-8576_0bf00238-038a-43dd-91bd-148aaa13f219
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204239
Listing Expiration 2026-12-31
Marketing Start 2015-12-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636298576
Hyphenated Format 63629-8576

Supplemental Identifiers

RxCUI
311347
UNII
ISQ9I6J12J
NUI
N0000175495 M0361132

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 ANDA204239 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (63629-8576-1)
source: ndc

Packages (1)

63629-8576-1 20 TABLET, FILM COATED in 1 BOTTLE (63629-8576-1)

Ingredients (1)

linezolid (600 mg/1)

Linked Drug Pages (1)

Linezolid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0bf00238-038a-43dd-91bd-148aaa13f219", "openfda": {"nui": ["N0000175495", "M0361132"], "unii": ["ISQ9I6J12J"], "rxcui": ["311347"], "spl_set_id": ["8a04bdc9-d6f0-4e35-b683-a472a2e4ff04"], "pharm_class_cs": ["Oxazolidinones [CS]"], "pharm_class_epc": ["Oxazolidinone Antibacterial [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (63629-8576-1)", "package_ndc": "63629-8576-1", "marketing_start_date": "20211216"}], "brand_name": "Linezolid", "product_id": "63629-8576_0bf00238-038a-43dd-91bd-148aaa13f219", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Oxazolidinone Antibacterial [EPC]", "Oxazolidinones [CS]"], "product_ndc": "63629-8576", "generic_name": "Linezolid", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Linezolid", "active_ingredients": [{"name": "LINEZOLID", "strength": "600 mg/1"}], "application_number": "ANDA204239", "marketing_category": "ANDA", "marketing_start_date": "20151221", "listing_expiration_date": "20261231"}