Bacitracin Zinc and Polymyxin B Sulfate
Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, Sterile
Approved
Approval ID
dc47903e-8d29-43eb-a647-1e8d28232bb9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 9, 2010
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 Code21695-156
Application NumberANDA064028
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bacitracin Zinc and Polymyxin B Sulfate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 27, 2009
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