Bacitracin Zinc and Polymyxin B Sulfate
Approved
Approval ID
064c3812-c664-40e3-a21b-b841757600d0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bacitracin Zinc and Polymyxin B Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-1199
Application NumberANDA064028
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bacitracin Zinc and Polymyxin B Sulfate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 30, 2010
FDA Product Classification
INGREDIENTS (4)
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 g
Code: 19371312D4
Classification: ACTIB
BACITRACIN ZINCActive
Quantity: 500 [USP'U] in 1 g
Code: 89Y4M234ES
Classification: ACTIB
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT