NEO-POLY-BAC HYDRO
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Ophthalmic Ointment, USP(Sterile)
Approved
Approval ID
6541631a-6c77-44fc-b6ac-3b91e42e3065
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 4, 2010
Manufacturers
FDA
Butler Animal Health Supply
DUNS: 017880659
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code11695-1406
Application NumberANDA064068
Product Classification
M
Marketing Category
C73584
G
Generic Name
Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 5, 2010
FDA Product Classification
INGREDIENTS (6)
BACITRACIN ZINCActive
Quantity: 400 [USP'U] in 1 g
Code: 89Y4M234ES
Classification: ACTIB
HYDROCORTISONEActive
Quantity: 10 mg in 1 g
Code: WI4X0X7BPJ
Classification: ACTIB
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 g
Code: 057Y626693
Classification: ACTIB
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 g
Code: 19371312D4
Classification: ACTIB