neomycin and polymyxin b sulfates and hydrocortisone

Generic: neomycin sulfate, polymyxin b sulfate and hydrocortisone

Labeler: sandoz inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name neomycin and polymyxin b sulfates and hydrocortisone
Generic Name neomycin sulfate, polymyxin b sulfate and hydrocortisone
Labeler sandoz inc.
Dosage Form SUSPENSION
Routes
AURICULAR (OTIC)
Active Ingredients

hydrocortisone 10 mg/mL, neomycin sulfate 3.5 mg/mL, polymyxin b sulfate 10000 [USP'U]/mL

Manufacturer
Sandoz Inc.

Identifiers & Regulatory

Product NDC 61314-645
Product ID 61314-645_99d0c7c1-3bf0-4491-b093-551555f7e80c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062488
Listing Expiration 2026-12-31
Marketing Start 2003-03-17

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61314645
Hyphenated Format 61314-645

Supplemental Identifiers

RxCUI
310687
UPC
0361314645111
UNII
WI4X0X7BPJ 057Y626693 19371312D4
NUI
N0000175576 N0000175450

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name neomycin and polymyxin b sulfates and hydrocortisone (source: ndc)
Generic Name neomycin sulfate, polymyxin b sulfate and hydrocortisone (source: ndc)
Application Number ANDA062488 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
  • 3.5 mg/mL
  • 10000 [USP'U]/mL
source: ndc
Packaging
  • 10 mL in 1 BOTTLE, PLASTIC (61314-645-11)
source: ndc

Packages (1)

61314-645-11 10 mL in 1 BOTTLE, PLASTIC (61314-645-11)

Ingredients (3)

hydrocortisone (10 mg/mL) neomycin sulfate (3.5 mg/mL) polymyxin b sulfate (10000 [USP'U]/mL)

Linked Drug Pages (1)

Neomycin and Polymyxin B Sulfates and Hydrocortisone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["AURICULAR (OTIC)"], "spl_id": "99d0c7c1-3bf0-4491-b093-551555f7e80c", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0361314645111"], "unii": ["WI4X0X7BPJ", "057Y626693", "19371312D4"], "rxcui": ["310687"], "spl_set_id": ["99d9030f-9118-412c-a377-d1df1c8fa723"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Sandoz Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 BOTTLE, PLASTIC (61314-645-11)", "package_ndc": "61314-645-11", "marketing_start_date": "20030317"}], "brand_name": "Neomycin and Polymyxin B Sulfates and Hydrocortisone", "product_id": "61314-645_99d0c7c1-3bf0-4491-b093-551555f7e80c", "dosage_form": "SUSPENSION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "61314-645", "generic_name": "neomycin sulfate, polymyxin b sulfate and hydrocortisone", "labeler_name": "Sandoz Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Neomycin and Polymyxin B Sulfates and Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "10 mg/mL"}, {"name": "NEOMYCIN SULFATE", "strength": "3.5 mg/mL"}, {"name": "POLYMYXIN B SULFATE", "strength": "10000 [USP'U]/mL"}], "application_number": "ANDA062488", "marketing_category": "ANDA", "marketing_start_date": "20030317", "listing_expiration_date": "20261231"}