linezolid

Generic: linezolid

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name linezolid
Generic Name linezolid
Labeler rising pharma holdings, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

linezolid 600 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-561
Product ID 64980-561_e7ccafc3-f287-4339-97d5-883922f99c74
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078845
Listing Expiration 2026-12-31
Marketing Start 2023-11-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64980561
Hyphenated Format 64980-561

Supplemental Identifiers

RxCUI
311347
UPC
0364980561020
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 ANDA078845 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 20 TABLET in 1 BOTTLE (64980-561-02)
  • 30 TABLET in 1 BOTTLE (64980-561-03)
source: ndc

Packages (2)

64980-561-02 20 TABLET in 1 BOTTLE (64980-561-02) 64980-561-03 30 TABLET in 1 BOTTLE (64980-561-03)

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": "e7ccafc3-f287-4339-97d5-883922f99c74", "openfda": {"nui": ["N0000175495", "M0361132"], "upc": ["0364980561020"], "unii": ["ISQ9I6J12J"], "rxcui": ["311347"], "spl_set_id": ["bf4fa35d-93c9-41c3-a2ae-0298014b8a9f"], "pharm_class_cs": ["Oxazolidinones [CS]"], "pharm_class_epc": ["Oxazolidinone Antibacterial [EPC]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET in 1 BOTTLE (64980-561-02)", "package_ndc": "64980-561-02", "marketing_start_date": "20231120"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (64980-561-03)", "package_ndc": "64980-561-03", "marketing_start_date": "20231120"}], "brand_name": "Linezolid", "product_id": "64980-561_e7ccafc3-f287-4339-97d5-883922f99c74", "dosage_form": "TABLET", "pharm_class": ["Oxazolidinone Antibacterial [EPC]", "Oxazolidinones [CS]"], "product_ndc": "64980-561", "generic_name": "Linezolid", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Linezolid", "active_ingredients": [{"name": "LINEZOLID", "strength": "600 mg/1"}], "application_number": "ANDA078845", "marketing_category": "ANDA", "marketing_start_date": "20231120", "listing_expiration_date": "20261231"}