Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate
Approved
Approval ID
e76c3a5a-d417-473b-ab9a-165d9d9963c6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 11, 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.
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6122
Application NumberANDA062166
Product Classification
M
Marketing Category
C73584
G
Generic Name
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMay 17, 2010
FDA Product Classification
INGREDIENTS (7)
ZINC CHLORIDEInactive
Code: 86Q357L16B
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 g
Code: 057Y626693
Classification: ACTIB
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 g
Code: 19371312D4
Classification: ACTIB
BACITRACIN ZINCActive
Quantity: 400 [USP'U] in 1 g
Code: 89Y4M234ES
Classification: ACTIB
HYDROCORTISONE ACETATEActive
Quantity: 10 mg in 1 g
Code: 3X7931PO74
Classification: ACTIB
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT