coly-mycin m

Generic: colistimethate

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name coly-mycin m
Generic Name colistimethate
Labeler endo usa, inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

colistimethate sodium 150 mg/2mL

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 42023-107
Product ID 42023-107_c8e9dd7e-ffbc-4d56-bdb7-fd41951bcee6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050108
Listing Expiration 2026-12-31
Marketing Start 2007-11-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42023107
Hyphenated Format 42023-107

Supplemental Identifiers

RxCUI
1117522 1117525
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 coly-mycin m (source: ndc)
Generic Name colistimethate (source: ndc)
Application Number NDA050108 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 150 mg/2mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (42023-107-01) / 2 mL in 1 VIAL
source: ndc

Packages (1)

42023-107-01 1 VIAL in 1 CARTON (42023-107-01) / 2 mL in 1 VIAL

Ingredients (1)

colistimethate sodium (150 mg/2mL)

Linked Drug Pages (1)

Coly-Mycin M ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "c8e9dd7e-ffbc-4d56-bdb7-fd41951bcee6", "openfda": {"unii": ["XW0E5YS77G"], "rxcui": ["1117522", "1117525"], "spl_set_id": ["6d6e13e2-dc33-4b7b-84d0-66146a57c552"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (42023-107-01)  / 2 mL in 1 VIAL", "package_ndc": "42023-107-01", "marketing_start_date": "20071101"}], "brand_name": "Coly-Mycin M", "product_id": "42023-107_c8e9dd7e-ffbc-4d56-bdb7-fd41951bcee6", "dosage_form": "INJECTION", "pharm_class": ["Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "42023-107", "generic_name": "colistimethate", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Coly-Mycin", "brand_name_suffix": "M", "active_ingredients": [{"name": "COLISTIMETHATE SODIUM", "strength": "150 mg/2mL"}], "application_number": "NDA050108", "marketing_category": "NDA", "marketing_start_date": "20071101", "listing_expiration_date": "20261231"}