linezolid

Generic: linezolid

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

Drug Facts

Product Profile

Brand Name linezolid
Generic Name linezolid
Labeler lupin pharmaceuticals,inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

linezolid 600 mg/1

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-022
Product ID 43386-022_74f11ed7-8e21-4310-975e-f88609d5aa4e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207526
Listing Expiration 2026-12-31
Marketing Start 2016-08-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43386022
Hyphenated Format 43386-022

Supplemental Identifiers

RxCUI
311347
UPC
0343386022052
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 ANDA207526 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING 16.2 Tablets Linezolid tablets, 600 mg, are white, oval, film-coated tablets, debossed with "n 022" on the one side and plain on other side. They are available as follows: Package Size NDC Number Bottle of 20 Tablets 43386-022-02 Bottle of 500 Tablets 43386-022-05 Unit-Dose Package of 30 Tablets (3 x 10) 43386-022-30 16.4 Storage and Handling Store at 25°C (77°F). Protect from light. Keep bottles tightly closed to protect from moisture.
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Linezolid Tablets, 600 mg Container Label 20 Count 500 Count 30 Units Dose Tablets - Carton Label 20 count 500 count carton
source: label

Packages (0)

No package records.

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": "74f11ed7-8e21-4310-975e-f88609d5aa4e", "openfda": {"nui": ["N0000175495", "M0361132"], "upc": ["0343386022052"], "unii": ["ISQ9I6J12J"], "rxcui": ["311347"], "spl_set_id": ["b3c55eb4-50f2-47f0-a424-5a6779518e1d"], "pharm_class_cs": ["Oxazolidinones [CS]"], "pharm_class_epc": ["Oxazolidinone Antibacterial [EPC]"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Linezolid", "product_id": "43386-022_74f11ed7-8e21-4310-975e-f88609d5aa4e", "dosage_form": "TABLET", "pharm_class": ["Oxazolidinone Antibacterial [EPC]", "Oxazolidinones [CS]"], "product_ndc": "43386-022", "generic_name": "Linezolid", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Linezolid", "active_ingredients": [{"name": "LINEZOLID", "strength": "600 mg/1"}], "application_number": "ANDA207526", "marketing_category": "ANDA", "marketing_start_date": "20160822", "listing_expiration_date": "20261231"}