neomycin polymyxin b sulfates and dexamethasone

Generic: neomycin sulfate, polymyxin b sulfate and dexamethasone

Labeler: nucare pharmaceuticals,inc.
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
Labeler nucare pharmaceuticals,inc.
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

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

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-4375
Product ID 68071-4375_1a555d03-b3db-da48-e063-6394a90a7576
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064135
Listing Expiration 2026-12-31
Marketing Start 1995-09-13

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 680714375
Hyphenated Format 68071-4375

Supplemental Identifiers

RxCUI
309680
UPC
0368071437553
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 (source: ndc)
Application Number ANDA064135 (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 BOX (68071-4375-5)
source: ndc

Packages (1)

68071-4375-5 5 mL in 1 BOX (68071-4375-5)

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": ["OPHTHALMIC"], "spl_id": "1a555d03-b3db-da48-e063-6394a90a7576", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0368071437553"], "unii": ["7S5I7G3JQL", "057Y626693", "19371312D4"], "rxcui": ["309680"], "spl_set_id": ["691bc5ca-5d61-60c2-e053-2991aa0abb93"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOX (68071-4375-5)", "package_ndc": "68071-4375-5", "marketing_start_date": "20180405"}], "brand_name": "Neomycin Polymyxin B Sulfates and Dexamethasone", "product_id": "68071-4375_1a555d03-b3db-da48-e063-6394a90a7576", "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": "68071-4375", "generic_name": "Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone", "labeler_name": "NuCare Pharmaceuticals,Inc.", "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": "19950913", "listing_expiration_date": "20261231"}