bacitracin

Generic: bacitracin

Labeler: padagis us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bacitracin
Generic Name bacitracin
Labeler padagis us llc
Dosage Form OINTMENT
Routes
OPHTHALMIC
Active Ingredients

bacitracin 500 [USP'U]/g

Manufacturer
Padagis US LLC

Identifiers & Regulatory

Product NDC 0574-4022
Product ID 0574-4022_cad3576e-8534-4132-ac3b-13919e15dc01
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA061212
Listing Expiration 2026-12-31
Marketing Start 2014-03-10

Pharmacologic Class

Physiologic Effect
decreased cell wall synthesis & repair [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05744022
Hyphenated Format 0574-4022

Supplemental Identifiers

RxCUI
308508
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 bacitracin (source: ndc)
Generic Name bacitracin (source: ndc)
Application Number ANDA061212 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 500 [USP'U]/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0574-4022-35) / 3.5 g in 1 TUBE
source: ndc

Packages (1)

0574-4022-35 1 TUBE in 1 CARTON (0574-4022-35) / 3.5 g in 1 TUBE

Ingredients (1)

bacitracin (500 [USP'U]/g)

Linked Drug Pages (1)

Bacitracin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "cad3576e-8534-4132-ac3b-13919e15dc01", "openfda": {"nui": ["N0000008479"], "unii": ["58H6RWO52I"], "rxcui": ["308508"], "spl_set_id": ["6ed2f2bd-9d2f-46af-a44c-95a02ca034de"], "pharm_class_pe": ["Decreased Cell Wall Synthesis & Repair [PE]"], "manufacturer_name": ["Padagis US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0574-4022-35)  / 3.5 g in 1 TUBE", "package_ndc": "0574-4022-35", "marketing_start_date": "20140310"}], "brand_name": "Bacitracin", "product_id": "0574-4022_cad3576e-8534-4132-ac3b-13919e15dc01", "dosage_form": "OINTMENT", "pharm_class": ["Decreased Cell Wall Synthesis & Repair [PE]"], "product_ndc": "0574-4022", "generic_name": "Bacitracin", "labeler_name": "Padagis US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bacitracin", "active_ingredients": [{"name": "BACITRACIN", "strength": "500 [USP'U]/g"}], "application_number": "ANDA061212", "marketing_category": "ANDA", "marketing_start_date": "20140310", "listing_expiration_date": "20261231"}