NDC 39822-0615

Colistimethate

Colistimethate

Colistimethate is a Intramuscular; Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by X-gen Pharmaceuticals, Inc.. The primary component is Colistimethate Sodium.

• Product ID: 39822-0615_0378b060-d796-428d-95d4-00bdef2b8266
• NDC: 39822-0615
• Product Type: Human Prescription Drug
• Proprietary Name: Colistimethate
• Generic Name: Colistimethate
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2011-01-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA064216
• Labeler Name: X-GEN Pharmaceuticals, 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: 2021-12-31

Packaging

NDC 39822-0615-2

12 CARTON in 1 CARTON (39822-0615-2) > 1 VIAL in 1 CARTON (39822-0615-1) > 2 mL in 1 VIAL

• Marketing Start Date: 2011-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 39822-0615-2 [39822061502]

Colistimethate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA064216
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-01-01

NDC 39822-0615-1 [39822061501]

Colistimethate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA064216
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-01-01

Drug Details

Active Ingredients

Ingredient	Strength
COLISTIMETHATE SODIUM	150 mg/2mL

OpenFDA Data

• SPL SET ID: ac75c6ee-e8eb-4bad-91d5-a58e64ba5d60
• Manufacturer:
  • X-GEN Pharmaceuticals, Inc.
• UNII:
  • XW0E5YS77G
• RxNorm Concept Unique ID - RxCUI:
  • 1117522
• UPC Code:
  • 0339822061518

Pharmacological Class

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

Medicade Reported Pricing

39822061501 COLISTIMETHATE 150 MG VIAL

Pricing Unit: EA | Drug Type:

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

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
42023-107	Coly-Mycin	colistimethate