sionbiotext triple antibiotic

Generic: bacitracin zinc, neomycin sulfate, polymyxin b sulfate

Labeler: sion biotext medical ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sionbiotext triple antibiotic
Generic Name bacitracin zinc, neomycin sulfate, polymyxin b sulfate
Labeler sion biotext medical ltd
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

bacitracin zinc 400 [USP'U]/g, neomycin sulfate .0035 g/g, polymyxin b sulfate 500 [USP'U]/g

Manufacturer
Sion Biotext Medical Ltd

Identifiers & Regulatory

Product NDC 68786-400
Product ID 68786-400_350833d3-f96d-fbf4-e063-6394a90ae819
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2025-05-13

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs] decreased cell wall synthesis & repair [pe] polymyxin-class antibacterial [epc] polymyxins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68786400
Hyphenated Format 68786-400

Supplemental Identifiers

RxCUI
2714198
UNII
89Y4M234ES 057Y626693 19371312D4

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 sionbiotext triple antibiotic (source: ndc)
Generic Name bacitracin zinc, neomycin sulfate, polymyxin b sulfate (source: ndc)
Application Number M004 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 400 [USP'U]/g
  • .0035 g/g
  • 500 [USP'U]/g
source: ndc
Packaging
  • 28.3 g in 1 TUBE (68786-400-28)
source: ndc

Packages (1)

68786-400-28 28.3 g in 1 TUBE (68786-400-28)

Ingredients (3)

bacitracin zinc (400 [USP'U]/g) neomycin sulfate (.0035 g/g) polymyxin b sulfate (500 [USP'U]/g)

Linked Drug Pages (1)

SionBiotext Triple Antibiotic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "350833d3-f96d-fbf4-e063-6394a90ae819", "openfda": {"unii": ["89Y4M234ES", "057Y626693", "19371312D4"], "rxcui": ["2714198"], "spl_set_id": ["35083d42-5823-eeb1-e063-6294a90acafa"], "manufacturer_name": ["Sion Biotext Medical Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28.3 g in 1 TUBE (68786-400-28)", "package_ndc": "68786-400-28", "marketing_start_date": "20250513"}], "brand_name": "SionBiotext Triple Antibiotic", "product_id": "68786-400_350833d3-f96d-fbf4-e063-6394a90ae819", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "68786-400", "generic_name": "Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate", "labeler_name": "Sion Biotext Medical Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SionBiotext Triple Antibiotic", "active_ingredients": [{"name": "BACITRACIN ZINC", "strength": "400 [USP'U]/g"}, {"name": "NEOMYCIN SULFATE", "strength": ".0035 g/g"}, {"name": "POLYMYXIN B SULFATE", "strength": "500 [USP'U]/g"}], "application_number": "M004", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250513", "listing_expiration_date": "20261231"}