neomycin and polymyxin b sulfates and dexamethasone

Generic: neomycin sulfate, polymyxin b sulfate and dexamethasone

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

Drug Facts

Product Profile

Brand Name neomycin and polymyxin b sulfates and dexamethasone
Generic Name neomycin sulfate, polymyxin b sulfate and dexamethasone
Labeler sandoz inc.
Dosage Form SUSPENSION
Routes
OPHTHALMIC
Active Ingredients

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

Manufacturer
Sandoz Inc.

Identifiers & Regulatory

Product NDC 61314-630
Product ID 61314-630_c28e6969-112d-49ae-b037-f09954e99f3e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062341
Listing Expiration 2026-12-31
Marketing Start 1996-02-21

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 61314630
Hyphenated Format 61314-630

Supplemental Identifiers

RxCUI
309680
UNII
7S5I7G3JQL 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 dexamethasone (source: ndc)
Generic Name neomycin sulfate, polymyxin b sulfate and dexamethasone (source: ndc)
Application Number ANDA062341 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
  • 3.5 mg/mL
  • 10000 [USP'U]/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE, PLASTIC (61314-630-06)
source: ndc

Packages (1)

61314-630-06 5 mL in 1 BOTTLE, PLASTIC (61314-630-06)

Ingredients (3)

dexamethasone (1 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 Dexamethasone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "c28e6969-112d-49ae-b037-f09954e99f3e", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["7S5I7G3JQL", "057Y626693", "19371312D4"], "rxcui": ["309680"], "spl_set_id": ["cf1a6da8-ba79-4bff-a13b-6effb67f6c1c"], "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": "5 mL in 1 BOTTLE, PLASTIC (61314-630-06)", "package_ndc": "61314-630-06", "marketing_start_date": "19960221"}], "brand_name": "Neomycin and Polymyxin B Sulfates and Dexamethasone", "product_id": "61314-630_c28e6969-112d-49ae-b037-f09954e99f3e", "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": "61314-630", "generic_name": "neomycin sulfate, polymyxin b sulfate and dexamethasone", "labeler_name": "Sandoz Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Neomycin and 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": "ANDA062341", "marketing_category": "ANDA", "marketing_start_date": "19960221", "listing_expiration_date": "20261231"}