bacitracin zinc and polymyxin b sulfate

Generic: bacitracin zinc and polymyxin b sulfate

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bacitracin zinc and polymyxin b sulfate
Generic Name bacitracin zinc and polymyxin b sulfate
Labeler nucare pharmaceuticals,inc.
Dosage Form OINTMENT
Routes
OPHTHALMIC
Active Ingredients

bacitracin zinc 500 [USP'U]/g, polymyxin b sulfate 10000 [USP'U]/g

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-5267
Product ID 68071-5267_2a849ae9-3395-4642-e063-6394a90a1ca4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064046
Listing Expiration 2026-12-31
Marketing Start 2008-04-25

Pharmacologic Class

Classes
decreased cell wall synthesis & repair [pe] polymyxin-class antibacterial [epc] polymyxins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680715267
Hyphenated Format 68071-5267

Supplemental Identifiers

RxCUI
308511
UPC
0368071526738
UNII
89Y4M234ES 19371312D4

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 zinc and polymyxin b sulfate (source: ndc)
Generic Name bacitracin zinc and polymyxin b sulfate (source: ndc)
Application Number ANDA064046 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 500 [USP'U]/g
  • 10000 [USP'U]/g
source: ndc
Packaging
  • 3.5 g in 1 BOX (68071-5267-3)
source: ndc

Packages (1)

68071-5267-3 3.5 g in 1 BOX (68071-5267-3)

Ingredients (2)

bacitracin zinc (500 [USP'U]/g) polymyxin b sulfate (10000 [USP'U]/g)

Linked Drug Pages (1)

Bacitracin Zinc and Polymyxin B Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "2a849ae9-3395-4642-e063-6394a90a1ca4", "openfda": {"upc": ["0368071526738"], "unii": ["89Y4M234ES", "19371312D4"], "rxcui": ["308511"], "spl_set_id": ["a73654f4-949d-3da4-e053-2995a90a1fc3"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "3.5 g in 1 BOX (68071-5267-3)", "package_ndc": "68071-5267-3", "marketing_start_date": "20200603"}], "brand_name": "Bacitracin Zinc and Polymyxin B Sulfate", "product_id": "68071-5267_2a849ae9-3395-4642-e063-6394a90a1ca4", "dosage_form": "OINTMENT", "pharm_class": ["Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "68071-5267", "generic_name": "Bacitracin Zinc and Polymyxin B Sulfate", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bacitracin Zinc and Polymyxin B Sulfate", "active_ingredients": [{"name": "BACITRACIN ZINC", "strength": "500 [USP'U]/g"}, {"name": "POLYMYXIN B SULFATE", "strength": "10000 [USP'U]/g"}], "application_number": "ANDA064046", "marketing_category": "ANDA", "marketing_start_date": "20080425", "listing_expiration_date": "20261231"}