single antibiotic

Generic: bacitracin zinc

Labeler: safetec of america, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name single antibiotic
Generic Name bacitracin zinc
Labeler safetec of america, inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

bacitracin zinc 500 [iU]/g

Manufacturer
Safetec of America, Inc.

Identifiers & Regulatory

Product NDC 61010-4404
Product ID 61010-4404_115cae29-9471-815f-e063-6294a90a25aa
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2019-11-01

Pharmacologic Class

Classes
decreased cell wall synthesis & repair [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 610104404
Hyphenated Format 61010-4404

Supplemental Identifiers

RxCUI
1366116
UNII
89Y4M234ES

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 single antibiotic (source: ndc)
Generic Name bacitracin zinc (source: ndc)
Application Number M004 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 500 [iU]/g
source: ndc
Packaging
  • 28.4 g in 1 TUBE (61010-4404-1)
source: ndc

Packages (1)

61010-4404-1 28.4 g in 1 TUBE (61010-4404-1)

Ingredients (1)

bacitracin zinc (500 [iU]/g)

Linked Drug Pages (1)

Single Antibiotic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "115cae29-9471-815f-e063-6294a90a25aa", "openfda": {"unii": ["89Y4M234ES"], "rxcui": ["1366116"], "spl_set_id": ["9993c204-6e61-4da3-90ef-2b7dfa09c920"], "manufacturer_name": ["Safetec of America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28.4 g in 1 TUBE (61010-4404-1)", "package_ndc": "61010-4404-1", "marketing_start_date": "20191101"}], "brand_name": "Single Antibiotic", "product_id": "61010-4404_115cae29-9471-815f-e063-6294a90a25aa", "dosage_form": "OINTMENT", "pharm_class": ["Decreased Cell Wall Synthesis & Repair [PE]"], "product_ndc": "61010-4404", "generic_name": "bacitracin zinc", "labeler_name": "Safetec of America, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Single Antibiotic", "active_ingredients": [{"name": "BACITRACIN ZINC", "strength": "500 [iU]/g"}], "application_number": "M004", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20191101", "listing_expiration_date": "20261231"}