Neomycin and Polymyxin B Sulfates and Hydrocortisone

Product NDC
68071-4577
11-digit product format
680714577
Labeler code
68071
Product ID
68071-4577_76dee8a5-f72c-178d-e053-2991aa0ac36c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
neomycin sulfate, polymyxin b sulfate and hydrocortisone
Dosage form
SUSPENSION
Route
AURICULAR (OTIC)
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA062488
Marketing category
ANDA
Marketing start
2003-03-17
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE
Active strength
4 mg/mL; [USP'U]/mL; mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record