colistimethate

Generic: colistimethate sodium

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name colistimethate
Generic Name colistimethate sodium
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

colistimethate sodium 150 mg/2mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-393
Product ID 63323-393_4637a207-5042-4af6-a7a7-e63cd472b0d3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065364
Listing Expiration 2026-12-31
Marketing Start 2009-12-04

Pharmacologic Class

Classes
polymyxin-class antibacterial [epc] polymyxins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323393
Hyphenated Format 63323-393

Supplemental Identifiers

RxCUI
1117522
UNII
XW0E5YS77G

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 colistimethate (source: ndc)
Generic Name colistimethate sodium (source: ndc)
Application Number ANDA065364 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 150 mg/2mL
source: ndc
Packaging
  • 1 VIAL in 1 BOX (63323-393-06) / 2 mL in 1 VIAL
source: ndc

Packages (1)

63323-393-06 1 VIAL in 1 BOX (63323-393-06) / 2 mL in 1 VIAL

Ingredients (1)

colistimethate sodium (150 mg/2mL)

Linked Drug Pages (1)

Colistimethate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "4637a207-5042-4af6-a7a7-e63cd472b0d3", "openfda": {"unii": ["XW0E5YS77G"], "rxcui": ["1117522"], "spl_set_id": ["ab241809-0d2f-44ba-829c-26be67ee623f"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BOX (63323-393-06)  / 2 mL in 1 VIAL", "package_ndc": "63323-393-06", "marketing_start_date": "20091204"}], "brand_name": "Colistimethate", "product_id": "63323-393_4637a207-5042-4af6-a7a7-e63cd472b0d3", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "63323-393", "generic_name": "COLISTIMETHATE SODIUM", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Colistimethate", "active_ingredients": [{"name": "COLISTIMETHATE SODIUM", "strength": "150 mg/2mL"}], "application_number": "ANDA065364", "marketing_category": "ANDA", "marketing_start_date": "20091204", "listing_expiration_date": "20261231"}