Neomycin and Polymyxin B sulfates, Bacitracin zinc
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP (Sterile)
Approved
Approval ID
27b51a77-a690-42ca-ad60-6f657202a198
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 5, 2017
Manufacturers
FDA
Casper Pharma LLC
DUNS: 080025838
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, Bacitracin zinc
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70199-010
Application NumberNDA050417
Product Classification
M
Marketing Category
C73594
G
Generic Name
Neomycin and Polymyxin B sulfates, Bacitracin zinc
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 9, 2017
FDA Product Classification
INGREDIENTS (4)
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 g
Code: 057Y626693
Classification: ACTIM
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 g
Code: 19371312D4
Classification: ACTIM
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
BACITRACIN ZINCActive
Quantity: 400 [USP'U] in 1 g
Code: 89Y4M234ES
Classification: ACTIM