NDC 63323-321

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 ID63323-321_545b3d1d-6c8f-44aa-b81e-b24fc99f9c82
NDC63323-321
Product TypeHuman Prescription Drug
Proprietary NamePOLYMYXIN B
Generic NamePolymyxin B Sulfate
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC
Marketing Start Date2009-11-17
Marketing CategoryANDA /
Application NumberANDA065372
Labeler NameFresenius Kabi USA, LLC
Substance NamePOLYMYXIN B SULFATE
Active Ingredient Strength500000 [USP'U]/1
Pharm ClassesPolymyxin-class Antibacterial [EPC],Polymyxins [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 63323-321-10

10 VIAL in 1 TRAY (63323-321-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-321-01)
Marketing Start Date2009-11-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-321-10 [63323032110]

Polymyxin B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA065372
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-17
Marketing End Date2015-12-07

Drug Details

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

NDCBrand NameGeneric Name
0143-9941Polymyxin BPolymyxin B sulfate
39822-0166Polymyxin BPolymyxin B
39822-0170Polymyxin BPolymyxin B
39822-0171Polymyxin BPolymyxin B
45932-0030POLYMYXIN BPOLYMYXIN B SULFATE
47781-596Polymyxin Bpolymyxin B sulfate
51991-939Polymyxin BPolymyxin B
55150-234Polymyxin BPolymyxin B
63323-321POLYMYXIN BPOLYMYXIN B SULFATE
63323-367POLYMYXIN BPOLYMYXIN B SULFATE
68083-174POLYMYXIN BPOLYMYXIN B SULFATE
70594-049Polymyxin BPolymyxin B Sulfate
70860-103Polymyxin Bpolymyxin B sulfate
70860-124Polymyxin Bpolymyxin B sulfate

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