neomycin polymyxin b sulfates and dexamethasone

Generic: neomycin sulfate, polymyxin b sulfate and dexamethasone suspension/ drops

Labeler: directrx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name neomycin polymyxin b sulfates and dexamethasone
Generic Name neomycin sulfate, polymyxin b sulfate and dexamethasone suspension/ drops
Labeler directrx
Dosage Form SUSPENSION/ DROPS
Routes
TOPICAL
Active Ingredients

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

Manufacturer
DirectRx

Identifiers & Regulatory

Product NDC 72189-320
Product ID 72189-320_32d607f3-fd60-9098-e063-6294a90a57af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064135
Listing Expiration 2026-12-31
Marketing Start 2022-01-18

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 72189320
Hyphenated Format 72189-320

Supplemental Identifiers

RxCUI
309680
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 polymyxin b sulfates and dexamethasone (source: ndc)
Generic Name neomycin sulfate, polymyxin b sulfate and dexamethasone suspension/ drops (source: ndc)
Application Number ANDA064135 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
  • 3.5 mg/mL
  • 10000 [USP'U]/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE (72189-320-05)
source: ndc

Packages (1)

72189-320-05 5 mL in 1 BOTTLE (72189-320-05)

Ingredients (3)

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

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "32d607f3-fd60-9098-e063-6294a90a57af", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["7S5I7G3JQL", "057Y626693", "19371312D4"], "rxcui": ["309680"], "spl_set_id": ["d5e00bad-abb4-63ad-e053-2a95a90a5abb"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["DirectRx"]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE (72189-320-05)", "package_ndc": "72189-320-05", "marketing_start_date": "20220118"}], "brand_name": "NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE", "product_id": "72189-320_32d607f3-fd60-9098-e063-6294a90a57af", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "72189-320", "generic_name": "neomycin sulfate, polymyxin b sulfate and dexamethasone suspension/ drops", "labeler_name": "DirectRx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": "1 mg/mL"}, {"name": "NEOMYCIN SULFATE", "strength": "3.5 mg/mL"}, {"name": "POLYMYXIN B SULFATE", "strength": "10000 [USP'U]/mL"}], "application_number": "ANDA064135", "marketing_category": "ANDA", "marketing_start_date": "20220118", "listing_expiration_date": "20261231"}