neomycin and polymyxin b sulfates and hydrocortisone otic suspension

Generic: neomycin and polymyxin b sulfates and hydrocortisone otic

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name neomycin and polymyxin b sulfates and hydrocortisone otic suspension
Generic Name neomycin and polymyxin b sulfates and hydrocortisone otic
Labeler rising pharma holdings, 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
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-448
Product ID 64980-448_4b15047c-4c19-4562-ba03-5c1aff192a2f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA060613
Listing Expiration 2026-12-31
Marketing Start 2019-03-15

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 64980448
Hyphenated Format 64980-448

Supplemental Identifiers

RxCUI
310687
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 otic suspension (source: ndc)
Generic Name neomycin and polymyxin b sulfates and hydrocortisone otic (source: ndc)
Application Number NDA060613 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
  • 3.5 mg/mL
  • 10000 [USP'U]/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (64980-448-01) / 10 mL in 1 BOTTLE
source: ndc

Packages (1)

64980-448-01 1 BOTTLE in 1 CARTON (64980-448-01) / 10 mL in 1 BOTTLE

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 Otic Suspension ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["AURICULAR (OTIC)"], "spl_id": "4b15047c-4c19-4562-ba03-5c1aff192a2f", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ", "057Y626693", "19371312D4"], "rxcui": ["310687"], "spl_set_id": ["35768adc-b578-4c2e-b461-22de3135a789"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (64980-448-01)  / 10 mL in 1 BOTTLE", "package_ndc": "64980-448-01", "marketing_start_date": "20190315"}], "brand_name": "Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension", "product_id": "64980-448_4b15047c-4c19-4562-ba03-5c1aff192a2f", "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": "64980-448", "generic_name": "neomycin and polymyxin B sulfates and hydrocortisone otic", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension", "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": "NDA060613", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20190315", "listing_expiration_date": "20261231"}