triple antibiotic

Generic: bacitracin zinc, neomycin, polymyxin b

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name triple antibiotic
Generic Name bacitracin zinc, neomycin, polymyxin b
Labeler padagis israel pharmaceuticals ltd
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

bacitracin zinc 400 [USP'U]/g, neomycin sulfate 3.5 mg/g, polymyxin b sulfate 5000 [USP'U]/g

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-143
Product ID 45802-143_007b5d54-72af-4d4e-a893-c6a79396b9b3
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2014-05-20

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 45802143
Hyphenated Format 45802-143

Supplemental Identifiers

RxCUI
204602
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 triple antibiotic (source: ndc)
Generic Name bacitracin zinc, neomycin, polymyxin b (source: ndc)
Application Number M004 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 400 [USP'U]/g
  • 3.5 mg/g
  • 5000 [USP'U]/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (45802-143-01) / 14 g in 1 TUBE
  • 1 TUBE in 1 CARTON (45802-143-03) / 28 g in 1 TUBE
  • 144 PACKET in 1 CARTON (45802-143-70) / .9 g in 1 PACKET (45802-143-00)
source: ndc

Packages (3)

Ingredients (3)

bacitracin zinc (400 [USP'U]/g) neomycin sulfate (3.5 mg/g) polymyxin b sulfate (5000 [USP'U]/g)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "007b5d54-72af-4d4e-a893-c6a79396b9b3", "openfda": {"unii": ["89Y4M234ES", "057Y626693", "19371312D4"], "rxcui": ["204602"], "spl_set_id": ["28fff253-ddd4-4669-aa90-b4caf48c905f"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (45802-143-01)  / 14 g in 1 TUBE", "package_ndc": "45802-143-01", "marketing_start_date": "20140520"}, {"sample": false, "description": "1 TUBE in 1 CARTON (45802-143-03)  / 28 g in 1 TUBE", "package_ndc": "45802-143-03", "marketing_start_date": "20140520"}, {"sample": false, "description": "144 PACKET in 1 CARTON (45802-143-70)  / .9 g in 1 PACKET (45802-143-00)", "package_ndc": "45802-143-70", "marketing_start_date": "20140520"}], "brand_name": "triple antibiotic", "product_id": "45802-143_007b5d54-72af-4d4e-a893-c6a79396b9b3", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "45802-143", "generic_name": "bacitracin zinc, neomycin, polymyxin B", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "triple antibiotic", "active_ingredients": [{"name": "BACITRACIN ZINC", "strength": "400 [USP'U]/g"}, {"name": "NEOMYCIN SULFATE", "strength": "3.5 mg/g"}, {"name": "POLYMYXIN B SULFATE", "strength": "5000 [USP'U]/g"}], "application_number": "M004", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20140520", "listing_expiration_date": "20261231"}