NDC 42023-107

Coly-Mycin M

Colistimethate

Coly-Mycin M is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical, Inc.. The primary component is Colistimethate Sodium.

• Product ID: 42023-107_267f327e-917a-4d07-ab24-3c0ac7e514b9
• NDC: 42023-107
• Product Type: Human Prescription Drug
• Proprietary Name: Coly-Mycin M
• Generic Name: Colistimethate
• Dosage Form: Injection
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2007-11-01
• Marketing Category: NDA / NDA
• Application Number: NDA050108
• Labeler Name: Par Pharmaceutical, Inc.
• Substance Name: COLISTIMETHATE SODIUM
• Active Ingredient Strength: 150 mg/2mL
• Pharm Classes: Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 42023-107-01

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

• Marketing Start Date: 2007-11-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42023-107-06 [42023010706]

Coly-Mycin M INJECTION

• Marketing Category: NDA
• Application Number: NDA050108
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2007-11-01

NDC 42023-107-01 [42023010701]

Coly-Mycin M INJECTION

• Marketing Category: NDA
• Application Number: NDA050108
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2007-11-01

Drug Details

Active Ingredients

Ingredient	Strength
COLISTIMETHATE SODIUM	150 mg/2mL

OpenFDA Data

• SPL SET ID: 6d6e13e2-dc33-4b7b-84d0-66146a57c552
• Manufacturer:
  • Par Pharmaceutical, Inc.
• UNII:
  • XW0E5YS77G
• RxNorm Concept Unique ID - RxCUI:
  • 1117525
  • 1117522

Pharmacological Class

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

NDC Crossover Matching brand name "Coly-Mycin M" or generic name "Colistimethate"

NDC	Brand Name	Generic Name
39822-0615	Colistimethate	Colistimethate
42023-107	Coly-Mycin	colistimethate