NDC 47781-596

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 Alvogen Inc.. The primary component is Polymyxin B Sulfate.

• Product ID: 47781-596_7d37b4f2-f498-cadf-ba64-bd70c6d514e4
• NDC: 47781-596
• 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: 2017-09-23
• Marketing Category: ANDA / ANDA
• Application Number: ANDA207322
• Labeler Name: Alvogen Inc.
• Substance Name: POLYMYXIN B SULFATE
• Active Ingredient Strength: 500000 [iU]/1
• Pharm Classes: Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 47781-596-91

10 VIAL in 1 CARTON (47781-596-91) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (47781-596-07)

• Marketing Start Date: 2017-09-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 47781-596-91 [47781059691]

Polymyxin B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA207322
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-09-23

NDC 47781-596-07 [47781059607]

Polymyxin B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA207322
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-09-23

Drug Details

Active Ingredients

Ingredient	Strength
POLYMYXIN B SULFATE	500000 [iU]/1

OpenFDA Data

• SPL SET ID: 14b5d61f-746a-cba3-72ee-f4f3eb8558c4
• Manufacturer:
  • Alvogen Inc.
• UNII:
  • 19371312D4
• RxNorm Concept Unique ID - RxCUI:
  • 204509
• UPC Code:
  • 0347781596910

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