neomycin and polymyxin b sulfates and dexamethasone

Generic: neomycin and polymyxin b sulfates and dexamethasone

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC 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 sandoz inc
Dosage Form OINTMENT
Routes
OPHTHALMIC
Active Ingredients

dexamethasone 1 mg/g, neomycin sulfate 3.5 mg/g, polymyxin b sulfate 10000 [iU]/g

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 61314-631
Product ID 61314-631_247c1988-9ae8-4e3c-80a0-7d88545fe6b3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA050065
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 61314631
Hyphenated Format 61314-631

Supplemental Identifiers

RxCUI
309679
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 and polymyxin b sulfates and dexamethasone (source: ndc)
Application Number NDA050065 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
  • 3.5 mg/g
  • 10000 [iU]/g
source: ndc
Packaging
  • 3.5 g in 1 TUBE (61314-631-36)
source: ndc

Packages (1)

61314-631-36 3.5 g in 1 TUBE (61314-631-36)

Ingredients (3)

dexamethasone (1 mg/g) neomycin sulfate (3.5 mg/g) polymyxin b sulfate (10000 [iU]/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": "247c1988-9ae8-4e3c-80a0-7d88545fe6b3", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["7S5I7G3JQL", "057Y626693", "19371312D4"], "rxcui": ["309679"], "spl_set_id": ["7f2e3c46-9f39-45e7-99a9-64cc4f6f649d"], "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": "3.5 g in 1 TUBE (61314-631-36)", "package_ndc": "61314-631-36", "marketing_start_date": "19960221"}], "brand_name": "Neomycin and Polymyxin B Sulfates and Dexamethasone", "product_id": "61314-631_247c1988-9ae8-4e3c-80a0-7d88545fe6b3", "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": "61314-631", "generic_name": "Neomycin and Polymyxin B Sulfates 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/g"}, {"name": "NEOMYCIN SULFATE", "strength": "3.5 mg/g"}, {"name": "POLYMYXIN B SULFATE", "strength": "10000 [iU]/g"}], "application_number": "NDA050065", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "19960221", "listing_expiration_date": "20261231"}