colistimethate

Generic: colistimethate sodium

Labeler: xellia pharmaceuticals usa llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

colistimethate sodium 150 mg/1

Manufacturer
Xellia Pharmaceuticals USA LLC

Identifiers & Regulatory

Product NDC 70594-023
Product ID 70594-023_ab4cbd6f-da57-4cb8-ae7f-5ae547b04b8a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205356
Listing Expiration 2026-12-31
Marketing Start 2018-10-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70594023
Hyphenated Format 70594-023

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 ANDA205356 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 VIAL (70594-023-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
  • 12 VIAL, GLASS in 1 CARTON (70594-023-04) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
source: ndc

Packages (2)

70594-023-01 1 VIAL, GLASS in 1 VIAL (70594-023-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS 70594-023-04 12 VIAL, GLASS in 1 CARTON (70594-023-04) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS

Ingredients (1)

colistimethate sodium (150 mg/1)

Linked Drug Pages (2)

Colistimethate ndc-match (0.9) Colistimethate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "ab4cbd6f-da57-4cb8-ae7f-5ae547b04b8a", "openfda": {"unii": ["XW0E5YS77G"], "rxcui": ["1117522"], "spl_set_id": ["8ec7dc90-825c-422e-9f4b-c8ace9d93af5"], "manufacturer_name": ["Xellia Pharmaceuticals USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 VIAL (70594-023-01)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS", "package_ndc": "70594-023-01", "marketing_start_date": "20181001"}, {"sample": false, "description": "12 VIAL, GLASS in 1 CARTON (70594-023-04)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS", "package_ndc": "70594-023-04", "marketing_start_date": "20181001"}], "brand_name": "Colistimethate", "product_id": "70594-023_ab4cbd6f-da57-4cb8-ae7f-5ae547b04b8a", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "70594-023", "generic_name": "Colistimethate Sodium", "labeler_name": "Xellia Pharmaceuticals USA LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Colistimethate", "active_ingredients": [{"name": "COLISTIMETHATE SODIUM", "strength": "150 mg/1"}], "application_number": "ANDA205356", "marketing_category": "ANDA", "marketing_start_date": "20181001", "listing_expiration_date": "20261231"}