Triple Antibiotic
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP (Sterile)
Approved
Approval ID
f7504b22-2d9e-4e2c-a308-1469bd5a1bab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 4, 2010
Manufacturers
FDA
Phoenix Pharmaceutical, Inc.
DUNS: 150711039
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Neomycin sulfate, Polymyxin B Sulfate and Bacitracin Zinc
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57319-343
Application NumberANDA064064
Product Classification
M
Marketing Category
C73584
G
Generic Name
Neomycin sulfate, Polymyxin B Sulfate and Bacitracin Zinc
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateSeptember 30, 2010
FDA Product Classification
INGREDIENTS (5)
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 g
Code: 19371312D4
Classification: ACTIB
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 g
Code: 057Y626693
Classification: ACTIB
BACITRACIN ZINCActive
Quantity: 400 [USP'U] in 1 g
Code: 89Y4M234ES
Classification: ACTIB
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT