neomycin and polymyxin b sulfates and dexamethasone

Generic: neomycin and polymyxin b sulfates and dexamethasone

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name neomycin and polymyxin b sulfates and dexamethasone
Generic Name neomycin and polymyxin b sulfates and dexamethasone
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form OINTMENT
Routes
OPHTHALMIC
Active Ingredients

dexamethasone 1 mg/g, neomycin sulfate 3.5 mg/g, polymyxin b sulfate 10000 [USP'U]/g

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0229
Product ID 80425-0229_2a9b1617-60d0-f8ce-e063-6294a90ab02c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064063
Listing Expiration 2026-12-31
Marketing Start 2023-01-11

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 804250229
Hyphenated Format 80425-0229

Supplemental Identifiers

RxCUI
309679
UNII
7S5I7G3JQL 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 dexamethasone (source: ndc)
Generic Name neomycin and polymyxin b sulfates and dexamethasone (source: ndc)
Application Number ANDA064063 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
  • 3.5 mg/g
  • 10000 [USP'U]/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (80425-0229-1) / 3.5 g in 1 TUBE
source: ndc

Packages (1)

80425-0229-1 1 TUBE in 1 CARTON (80425-0229-1) / 3.5 g in 1 TUBE

Ingredients (3)

dexamethasone (1 mg/g) neomycin sulfate (3.5 mg/g) polymyxin b sulfate (10000 [USP'U]/g)

Linked Drug Pages (1)

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "2a9b1617-60d0-f8ce-e063-6294a90ab02c", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["7S5I7G3JQL", "057Y626693", "19371312D4"], "rxcui": ["309679"], "spl_set_id": ["f1a05d5f-74f2-17a1-e053-2995a90ab0e7"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (80425-0229-1)  / 3.5 g in 1 TUBE", "package_ndc": "80425-0229-1", "marketing_start_date": "20230111"}], "brand_name": "NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE", "product_id": "80425-0229_2a9b1617-60d0-f8ce-e063-6294a90ab02c", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "80425-0229", "generic_name": "NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": "1 mg/g"}, {"name": "NEOMYCIN SULFATE", "strength": "3.5 mg/g"}, {"name": "POLYMYXIN B SULFATE", "strength": "10000 [USP'U]/g"}], "application_number": "ANDA064063", "marketing_category": "ANDA", "marketing_start_date": "20230111", "listing_expiration_date": "20261231"}