antibiotic

Generic: bacitracin

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name antibiotic
Generic Name bacitracin
Labeler topco associates llc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

bacitracin 500 [USP'U]/g

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-536
Product ID 36800-536_3c4b9bbd-b6bf-4e7d-880e-c4c360ca739a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2020-04-03

Pharmacologic Class

Physiologic Effect
decreased cell wall synthesis & repair [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800536
Hyphenated Format 36800-536

Supplemental Identifiers

RxCUI
1648110
UNII
58H6RWO52I
NUI
N0000008479

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

Resolved Composition

Strengths
  • 500 [USP'U]/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (36800-536-64) / 28 g in 1 TUBE
source: ndc

Packages (1)

36800-536-64 1 TUBE in 1 CARTON (36800-536-64) / 28 g in 1 TUBE

Ingredients (1)

bacitracin (500 [USP'U]/g)

Linked Drug Pages (1)

Antibiotic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3c4b9bbd-b6bf-4e7d-880e-c4c360ca739a", "openfda": {"nui": ["N0000008479"], "unii": ["58H6RWO52I"], "rxcui": ["1648110"], "spl_set_id": ["3267a695-9e53-42f2-b30a-022653a0b8bb"], "pharm_class_pe": ["Decreased Cell Wall Synthesis & Repair [PE]"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (36800-536-64)  / 28 g in 1 TUBE", "package_ndc": "36800-536-64", "marketing_start_date": "20200403"}], "brand_name": "Antibiotic", "product_id": "36800-536_3c4b9bbd-b6bf-4e7d-880e-c4c360ca739a", "dosage_form": "OINTMENT", "pharm_class": ["Decreased Cell Wall Synthesis & Repair [PE]"], "product_ndc": "36800-536", "generic_name": "bacitracin", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Antibiotic", "active_ingredients": [{"name": "BACITRACIN", "strength": "500 [USP'U]/g"}], "application_number": "M004", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200403", "listing_expiration_date": "20261231"}