Neo Polycin HC
Neo-Polycin® HC neomycin and polymyxin B sulfates, bacitracin zinc, and hydrocortisone acetate Ophthalmic Ointment USPSTERILE Rx Only
Approved
Approval ID
c9996e7a-36f0-4e2e-b887-91d1d06b326e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 2021
Manufacturers
FDA
Padagis US LLC
DUNS: 967694121
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 and hydrocortisone acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0574-4144
Application NumberANDA062166
Product Classification
M
Marketing Category
C73584
G
Generic Name
neomycin and polymyxin b sulfates, bacitracin zinc and hydrocortisone acetate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 9, 2018
FDA Product Classification
INGREDIENTS (6)
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
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
HYDROCORTISONE ACETATEActive
Quantity: 10 mg in 1 g
Code: 3X7931PO74
Classification: ACTIB
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT