Bacitracin Zinc and Polymyxin B Sulfate
Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP (Sterile)
Approved
Approval ID
c6c69fa4-d7be-4c09-b7fa-53c40fad78a7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 16, 2012
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.
Bacitracin Zinc and Polymyxin B Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42254-154
Application NumberANDA064046
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bacitracin Zinc and Polymyxin B Sulfate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateApril 1, 2008
FDA Product Classification
INGREDIENTS (4)
BACITRACIN ZINCActive
Quantity: 500 1 in 1 g
Code: 89Y4M234ES
Classification: ACTIB
POLYMYXIN B SULFATEActive
Quantity: 10000 1 in 1 g
Code: 19371312D4
Classification: ACTIB
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT