neomycin and polymyxin b sulfates and hydrocortisone

Generic: neomycin sulfate, polymyxin b sulfate, hydrocortisone

Labeler: asclemed usa, 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, hydrocortisone
Labeler asclemed usa, inc.
Dosage Form SOLUTION/ DROPS
Routes
AURICULAR (OTIC)
Active Ingredients

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

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-104
Product ID 76420-104_b2ddcdd0-72c2-99df-e053-2a95a90a8818
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064053
Listing Expiration 2026-12-31
Marketing Start 1995-12-29

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 76420104
Hyphenated Format 76420-104

Supplemental Identifiers

RxCUI
204423
UNII
WI4X0X7BPJ 057Y626693 19371312D4
NUI
N0000175576 N0000175450

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, hydrocortisone (source: ndc)
Application Number ANDA064053 (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, DROPPER (76420-104-10)
source: ndc

Packages (1)

76420-104-10 10 mL in 1 BOTTLE, DROPPER (76420-104-10)

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": "b2ddcdd0-72c2-99df-e053-2a95a90a8818", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ", "057Y626693", "19371312D4"], "rxcui": ["204423"], "spl_set_id": ["7c78ec84-8b7c-42f1-a879-3bf27a1daa71"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 BOTTLE, DROPPER (76420-104-10)", "package_ndc": "76420-104-10", "marketing_start_date": "20201030"}], "brand_name": "Neomycin and Polymyxin B Sulfates and Hydrocortisone", "product_id": "76420-104_b2ddcdd0-72c2-99df-e053-2a95a90a8818", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "76420-104", "generic_name": "Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone", "labeler_name": "Asclemed USA, 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": "ANDA064053", "marketing_category": "ANDA", "marketing_start_date": "19951229", "listing_expiration_date": "20261231"}