NDC 70594-023

Colistimethate

Colistimethate Sodium

Colistimethate is a Intramuscular; Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Xellia Pharmaceuticals Usa Llc. The primary component is Colistimethate Sodium.

• Product ID: 70594-023_6898f29c-f0b8-4483-a4f0-13315b990eb1
• NDC: 70594-023
• Product Type: Human Prescription Drug
• Proprietary Name: Colistimethate
• Generic Name: Colistimethate Sodium
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2018-10-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA205356
• Labeler Name: Xellia Pharmaceuticals USA LLC
• Substance Name: COLISTIMETHATE SODIUM
• Active Ingredient Strength: 150 mg/1
• Pharm Classes: Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 70594-023-01

1 VIAL, GLASS in 1 VIAL (70594-023-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS

• Marketing Start Date: 2018-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70594-023-01 [70594002301]

Colistimethate INJECTION, POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA205356
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-10-01

NDC 70594-023-04 [70594002304]

Colistimethate INJECTION, POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA205356
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-10-01

Drug Details

Active Ingredients

Ingredient	Strength
COLISTIMETHATE SODIUM	150 mg/1

OpenFDA Data

• SPL SET ID: 8ec7dc90-825c-422e-9f4b-c8ace9d93af5
• Manufacturer:
  • Xellia Pharmaceuticals USA LLC
• UNII:
  • XW0E5YS77G
• RxNorm Concept Unique ID - RxCUI:
  • 1117522

Pharmacological Class

• Polymyxin-class Antibacterial [EPC]
• Polymyxins [CS]

NDC Crossover Matching brand name "Colistimethate" or generic name "Colistimethate Sodium"

NDC	Brand Name	Generic Name
25021-159	Colistimethate	colistimethate sodium
39822-0615	Colistimethate	Colistimethate
39822-0617	Colistimethate	colistimethate sodium
42023-131	Colistimethate	colistimethate sodium
45932-0023	Colistimethate	colistimethate sodium
63323-393	Colistimethate	COLISTIMETHATE SODIUM
70594-023	Colistimethate	Colistimethate Sodium
14789-201	Colistimethate Sodium	Colistimethate Sodium
23155-193	COLISTIMETHATE SODIUM	COLISTIMETHATE SODIUM
42023-107	Coly-Mycin	colistimethate