polymyxin b

Generic: polymyxin b sulfate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name polymyxin b
Generic Name polymyxin b sulfate
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAMUSCULAR INTRATHECAL INTRAVENOUS OPHTHALMIC
Active Ingredients

polymyxin b sulfate 500000 [USP'U]/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9461
Product ID 0143-9461_d87f8155-092a-4dd0-8325-417a0ed8f167
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202766
Listing Expiration 2027-12-31
Marketing Start 2025-09-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439461
Hyphenated Format 0143-9461

Supplemental Identifiers

RxCUI
204509
UPC
0301439461012
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 sulfate (source: ndc)
Application Number ANDA202766 (source: ndc)
Routes
INTRAMUSCULAR INTRATHECAL INTRAVENOUS OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 500000 [USP'U]/1
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (0143-9461-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
  • 10 VIAL, GLASS in 1 CARTON (0143-9461-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
source: ndc

Packages (2)

0143-9461-01 1 VIAL, GLASS in 1 CARTON (0143-9461-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS 0143-9461-10 10 VIAL, GLASS in 1 CARTON (0143-9461-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS

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": "d87f8155-092a-4dd0-8325-417a0ed8f167", "openfda": {"upc": ["0301439461012"], "unii": ["19371312D4"], "rxcui": ["204509"], "spl_set_id": ["d2bf65f6-2763-4859-a665-ad5e6cde71ee"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (0143-9461-01)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS", "package_ndc": "0143-9461-01", "marketing_start_date": "20250930"}, {"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (0143-9461-10)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS", "package_ndc": "0143-9461-10", "marketing_start_date": "20250930"}], "brand_name": "Polymyxin B", "product_id": "0143-9461_d87f8155-092a-4dd0-8325-417a0ed8f167", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "0143-9461", "generic_name": "Polymyxin B Sulfate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Polymyxin B", "active_ingredients": [{"name": "POLYMYXIN B SULFATE", "strength": "500000 [USP'U]/1"}], "application_number": "ANDA202766", "marketing_category": "ANDA", "marketing_start_date": "20250930", "listing_expiration_date": "20271231"}