linezolid

Generic: linezolid

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name linezolid
Generic Name linezolid
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

linezolid 600 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-183
Product ID 46708-183_9ce8d5c0-4471-43ca-a988-f8b741b44178
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205233
Listing Expiration 2026-12-31
Marketing Start 2015-12-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708183
Hyphenated Format 46708-183

Supplemental Identifiers

RxCUI
311347
UPC
0346708183318
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 ANDA205233 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (46708-183-20)
  • 30 TABLET, FILM COATED in 1 BOTTLE (46708-183-30)
  • 100 TABLET, FILM COATED in 1 BOTTLE (46708-183-31)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (46708-183-91)
source: ndc

Packages (4)

46708-183-20 20 TABLET, FILM COATED in 1 BOTTLE (46708-183-20) 46708-183-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-183-30) 46708-183-31 100 TABLET, FILM COATED in 1 BOTTLE (46708-183-31) 46708-183-91 1000 TABLET, FILM COATED in 1 BOTTLE (46708-183-91)

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": "9ce8d5c0-4471-43ca-a988-f8b741b44178", "openfda": {"nui": ["N0000175495", "M0361132"], "upc": ["0346708183318"], "unii": ["ISQ9I6J12J"], "rxcui": ["311347"], "spl_set_id": ["74f035ec-a0b1-4371-a17b-20b0b11864c9"], "pharm_class_cs": ["Oxazolidinones [CS]"], "pharm_class_epc": ["Oxazolidinone Antibacterial [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (46708-183-20)", "package_ndc": "46708-183-20", "marketing_start_date": "20151222"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (46708-183-30)", "package_ndc": "46708-183-30", "marketing_start_date": "20151222"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (46708-183-31)", "package_ndc": "46708-183-31", "marketing_start_date": "20151222"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (46708-183-91)", "package_ndc": "46708-183-91", "marketing_start_date": "20151222"}], "brand_name": "Linezolid", "product_id": "46708-183_9ce8d5c0-4471-43ca-a988-f8b741b44178", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Oxazolidinone Antibacterial [EPC]", "Oxazolidinones [CS]"], "product_ndc": "46708-183", "generic_name": "Linezolid", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Linezolid", "active_ingredients": [{"name": "LINEZOLID", "strength": "600 mg/1"}], "application_number": "ANDA205233", "marketing_category": "ANDA", "marketing_start_date": "20151222", "listing_expiration_date": "20261231"}