NDC 55150-234

Polymyxin B

Polymyxin B

Polymyxin B is a Intramuscular; Intrathecal; Intravenous; Ophthalmic Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Auromedics Pharma Llc. The primary component is Polymyxin B Sulfate.

• Product ID: 55150-234_04505c5f-d24d-4fba-9f17-8d14229a8b48
• NDC: 55150-234
• Product Type: Human Prescription Drug
• Proprietary Name: Polymyxin B
• Generic Name: Polymyxin B
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC
• Marketing Start Date: 2016-04-04
• Marketing Category: ANDA / ANDA
• Application Number: ANDA206589
• Labeler Name: AuroMedics Pharma LLC
• Substance Name: POLYMYXIN B SULFATE
• Active Ingredient Strength: 500000 [USP'U]/1
• Pharm Classes: Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 55150-234-10

10 VIAL in 1 CARTON (55150-234-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

• Marketing Start Date: 2016-04-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55150-234-10 [55150023410]

Polymyxin B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA206589
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-04-04

Drug Details

Active Ingredients

Ingredient	Strength
POLYMYXIN B SULFATE	500000 [USP'U]/1

OpenFDA Data

• SPL SET ID: a974c557-e88f-451b-a1bd-d2c656be226e
• Manufacturer:
  • AuroMedics Pharma LLC
• UNII:
  • 19371312D4
• RxNorm Concept Unique ID - RxCUI:
  • 204509
• UPC Code:
  • 0355150234103

Pharmacological Class

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

NDC Crossover Matching brand name "Polymyxin B" or generic name "Polymyxin B"

NDC	Brand Name	Generic Name
0143-9941	Polymyxin B	Polymyxin B sulfate
39822-0166	Polymyxin B	Polymyxin B
39822-0170	Polymyxin B	Polymyxin B
39822-0171	Polymyxin B	Polymyxin B
45932-0030	POLYMYXIN B	POLYMYXIN B SULFATE
47781-596	Polymyxin B	polymyxin B sulfate
51991-939	Polymyxin B	Polymyxin B
55150-234	Polymyxin B	Polymyxin B
63323-321	POLYMYXIN B	POLYMYXIN B SULFATE
63323-367	POLYMYXIN B	POLYMYXIN B SULFATE
68083-174	POLYMYXIN B	POLYMYXIN B SULFATE
70594-049	Polymyxin B	Polymyxin B Sulfate
70860-103	Polymyxin B	polymyxin B sulfate
70860-124	Polymyxin B	polymyxin B sulfate