Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate
NEOMYCIN and POLYMYXIN B SULFATES and BACITRACIN ZINC with HYDROCORTISONE ACETATE OPHTHALMIC OINTMENT
Approved
Approval ID
bdee074e-e813-4403-897c-1ccb32bd6548
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-736
Application NumberANDA062166
Product Classification
M
Marketing Category
C73584
G
Generic Name
Neomycin sulfate and Polymyxin B Sulfate, Bacitracin zinc and Hydrocortisone Acetate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateSeptember 12, 2006
FDA Product Classification
INGREDIENTS (7)
Neomycin SulfateActive
Quantity: 3.5 mg in 1 g
Code: 057Y626693
Classification: ACTIB
Hydrocortisone AcetateActive
Quantity: 10 mg in 1 g
Code: 3X7931PO74
Classification: ACTIB
Polymyxin B SulfateActive
Quantity: 10000 g in 1 g
Code: 19371312D4
Classification: ACTIB
Bacitracin zincActive
Quantity: 400 g in 1 g
Code: 89Y4M234ES
Classification: ACTIB
Zinc chlorideInactive
Code: 86Q357L16B
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT