antibiotic application

Generic: bacitracin zinc, neomycin sulfate, polymyxin b sulfate

Labeler: cmc group, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name antibiotic application
Generic Name bacitracin zinc, neomycin sulfate, polymyxin b sulfate
Labeler cmc group, inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

bacitracin zinc 400 [iU]/g, neomycin sulfate 3.5 mg/g, polymyxin b sulfate 5000 [iU]/g

Manufacturer
CMC Group, Inc.

Identifiers & Regulatory

Product NDC 49687-0013
Product ID 49687-0013_2b9b528b-164e-a4d3-e063-6294a90a5318
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M003
Listing Expiration 2026-12-31
Marketing Start 2016-08-06

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 496870013
Hyphenated Format 49687-0013

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 antibiotic application (source: ndc)
Generic Name bacitracin zinc, neomycin sulfate, polymyxin b sulfate (source: ndc)
Application Number M003 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 400 [iU]/g
  • 3.5 mg/g
  • 5000 [iU]/g
source: ndc
Packaging
  • 10 PACKAGE in 1 KIT (49687-0013-0) / .9 g in 1 PACKAGE
source: ndc

Packages (1)

49687-0013-0 10 PACKAGE in 1 KIT (49687-0013-0) / .9 g in 1 PACKAGE

Ingredients (3)

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

Linked Drug Pages (1)

Antibiotic Application ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2b9b528b-164e-a4d3-e063-6294a90a5318", "openfda": {"unii": ["89Y4M234ES", "057Y626693", "19371312D4"], "rxcui": ["204602"], "spl_set_id": ["da436c35-a98f-4df7-9d23-885564734cef"], "manufacturer_name": ["CMC Group, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 PACKAGE in 1 KIT (49687-0013-0)  / .9 g in 1 PACKAGE", "package_ndc": "49687-0013-0", "marketing_start_date": "20160806"}], "brand_name": "Antibiotic Application", "product_id": "49687-0013_2b9b528b-164e-a4d3-e063-6294a90a5318", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "49687-0013", "generic_name": "BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE", "labeler_name": "CMC Group, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Antibiotic Application", "active_ingredients": [{"name": "BACITRACIN ZINC", "strength": "400 [iU]/g"}, {"name": "NEOMYCIN SULFATE", "strength": "3.5 mg/g"}, {"name": "POLYMYXIN B SULFATE", "strength": "5000 [iU]/g"}], "application_number": "M003", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160806", "listing_expiration_date": "20261231"}