NDC 81607-014

Neomycin and Polymyxin B sulfates and HydrocortisoneOTIC 10 mg per 1 mL / 3.5 mg per 1 mL / 10000 [iU] per 1 mL solution/ drops

On the label: Orbicular Pharmaceutical Technologies Private Limited.

India: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Gland Pharma LimitedHyderabad, IndiaMakes it, tests it, packages it and labels it Problems found, fixed voluntarilyJul 25, 2024 · 7 inspections

Product details

Generic drug
Hydrocortisone and Neomycin and Polymyxin B: every company that makes it
Form
solution/ drops, auricular (otic)
Strength
10 mg per 1 mL / 3.5 mg per 1 mL / 10000 [iU] per 1 mL
Approval
ANDA ANDA220938
On the market since
Oct 8, 2026
Package NDCs
81607-014-10
Official label
DailyMed (National Library of Medicine), updated Oct 14, 2026

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