polymyxin b

Generic: polymyxin b sulfate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name polymyxin b
Generic Name polymyxin b sulfate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR INTRATHECAL INTRAVENOUS OPHTHALMIC
Active Ingredients

polymyxin b sulfate 500000 [USP'U]/1

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-321
Product ID 63323-321_545b3d1d-6c8f-44aa-b81e-b24fc99f9c82
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065372
Listing Expiration 2026-12-31
Marketing Start 2009-11-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323321
Hyphenated Format 63323-321

Supplemental Identifiers

RxCUI
204509
UPC
0363323321017
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 ANDA065372 (source: ndc)
Routes
INTRAMUSCULAR INTRATHECAL INTRAVENOUS OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 500000 [USP'U]/1
source: ndc
Packaging
  • 10 VIAL in 1 TRAY (63323-321-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-321-01)
source: ndc

Packages (1)

63323-321-10 10 VIAL in 1 TRAY (63323-321-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-321-01)

Ingredients (1)

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

Linked Drug Pages (2)

POLYMYXIN B ndc-match (0.9) POLYMYXIN B ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRATHECAL", "INTRAVENOUS", "OPHTHALMIC"], "spl_id": "545b3d1d-6c8f-44aa-b81e-b24fc99f9c82", "openfda": {"upc": ["0363323321017"], "unii": ["19371312D4"], "rxcui": ["204509"], "spl_set_id": ["fbc12c18-567b-41bc-89d0-efd29616615c"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 TRAY (63323-321-10)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-321-01)", "package_ndc": "63323-321-10", "marketing_start_date": "20091117"}], "brand_name": "POLYMYXIN B", "product_id": "63323-321_545b3d1d-6c8f-44aa-b81e-b24fc99f9c82", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "63323-321", "generic_name": "POLYMYXIN B SULFATE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "POLYMYXIN B", "active_ingredients": [{"name": "POLYMYXIN B SULFATE", "strength": "500000 [USP'U]/1"}], "application_number": "ANDA065372", "marketing_category": "ANDA", "marketing_start_date": "20091117", "listing_expiration_date": "20261231"}