NDC 63323-367

POLYMYXIN B

Polymyxin B Sulfate

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 Fresenius Kabi Usa, Llc. The primary component is Polymyxin B Sulfate.

• Product ID: 63323-367_33311f2b-4ec3-45e7-bb3d-bd826ab06ed0
• NDC: 63323-367
• Product Type: Human Prescription Drug
• Proprietary Name: POLYMYXIN B
• Generic Name: Polymyxin B Sulfate
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC
• Marketing Start Date: 2015-09-09
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202766
• Labeler Name: Fresenius Kabi USA, 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: 2021-12-31

Packaging

NDC 63323-367-11

10 VIAL in 1 CARTON (63323-367-11) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-367-01)

• Marketing Start Date: 2015-09-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-367-41 [63323036741]

POLYMYXIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA202766
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-09-09

NDC 63323-367-11 [63323036711]

POLYMYXIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA202766
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-09-09

NDC 63323-367-44 [63323036744]

POLYMYXIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA202766
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-09-09

Drug Details

Active Ingredients

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

OpenFDA Data

• SPL SET ID: 1d57c007-5019-4f88-a927-4a186c25d912
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • 19371312D4
• RxNorm Concept Unique ID - RxCUI:
  • 204509

Pharmacological Class

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

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

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