Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc
apexa™Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP
Approved
Approval ID
0f651b47-ef7e-4d07-b3b1-8baade8b9031
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 2, 2022
Manufacturers
FDA
MWI
DUNS: 019926120
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 Code13985-607
Application NumberANDA065088
Product Classification
M
Marketing Category
C73584
G
Generic Name
Neomycin Sulfate, Polymyxin B Sulfate and Bacitracin Zinc
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 23, 2015
FDA Product Classification
INGREDIENTS (4)
Neomycin SulfateActive
Quantity: 3.5 mg in 1 g
Code: 057Y626693
Classification: ACTIM
Bacitracin ZincActive
Quantity: 400 [USP'U] in 1 g
Code: 89Y4M234ES
Classification: ACTIM
PetrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
Polymyxin B SulfateActive
Quantity: 10000 [USP'U] in 1 g
Code: 19371312D4
Classification: ACTIM