Neomycin and Polymyxin B Sulfates and Bacitracin Zinc
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP
Approved
Approval ID
65b71a14-dcb5-4123-b4c5-033c9e16a22a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-192
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 DateMarch 30, 2007
FDA Product Classification
INGREDIENTS (5)
Neomycin SulfateActive
Quantity: 3.5 mg in 1 g
Code: 057Y626693
Classification: ACTIB
Polymyxin B SulfateActive
Quantity: 10000 mg in 1 g
Code: 19371312D4
Classification: ACTIB
Bacitracin ZincActive
Quantity: 400 ug in 1 g
Code: 89Y4M234ES
Classification: ACTIB
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT