polymyxin b

Generic: polymyxin b

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

Drug Facts

Product Profile

Brand Name polymyxin b
Generic Name polymyxin b
Labeler eugia us llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR INTRATHECAL INTRAVENOUS OPHTHALMIC
Active Ingredients

polymyxin b sulfate 500000 [USP'U]/1

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-234
Product ID 55150-234_097fa44b-506b-4ee0-9f64-4b560c3ed41c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206589
Listing Expiration 2026-12-31
Marketing Start 2016-04-04

Pharmacologic Class

Classes
polymyxin-class antibacterial [epc] polymyxins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150234
Hyphenated Format 55150-234

Supplemental Identifiers

RxCUI
204509
UPC
0355150234103
UNII
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 polymyxin b (source: ndc)
Generic Name polymyxin b (source: ndc)
Application Number ANDA206589 (source: ndc)
Routes
INTRAMUSCULAR INTRATHECAL INTRAVENOUS OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 500000 [USP'U]/1
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (55150-234-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
source: ndc

Packages (1)

55150-234-10 10 VIAL in 1 CARTON (55150-234-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Ingredients (1)

polymyxin b sulfate (500000 [USP'U]/1)

Linked Drug Pages (1)

Polymyxin B ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRATHECAL", "INTRAVENOUS", "OPHTHALMIC"], "spl_id": "097fa44b-506b-4ee0-9f64-4b560c3ed41c", "openfda": {"upc": ["0355150234103"], "unii": ["19371312D4"], "rxcui": ["204509"], "spl_set_id": ["a974c557-e88f-451b-a1bd-d2c656be226e"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (55150-234-10)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL", "package_ndc": "55150-234-10", "marketing_start_date": "20160404"}], "brand_name": "Polymyxin B", "product_id": "55150-234_097fa44b-506b-4ee0-9f64-4b560c3ed41c", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "55150-234", "generic_name": "Polymyxin B", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Polymyxin B", "active_ingredients": [{"name": "POLYMYXIN B SULFATE", "strength": "500000 [USP'U]/1"}], "application_number": "ANDA206589", "marketing_category": "ANDA", "marketing_start_date": "20160404", "listing_expiration_date": "20261231"}