Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone
apexa™Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone
Approved
Approval ID
f914f577-32aa-4b7a-9996-ca24b34f022d
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, Bacitracin Zinc and Hydrocortisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13985-608
Application NumberANDA065213
Product Classification
M
Marketing Category
C73584
G
Generic Name
Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 23, 2015
FDA Product Classification
INGREDIENTS (5)
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
Bacitracin ZincActive
Quantity: 400 [USP'U] in 1 g
Code: 89Y4M234ES
Classification: ACTIM
HydrocortisoneActive
Quantity: 10 mg in 1 g
Code: WI4X0X7BPJ
Classification: ACTIB
PetrolatumInactive
Code: 4T6H12BN9U
Classification: IACT