polymyxin b

Generic: polymyxin b sulfate

Labeler: xellia pharmaceuticals usa llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

polymyxin b sulfate 500000 [USP'U]/1

Manufacturer
Xellia Pharmaceuticals USA LLC

Identifiers & Regulatory

Product NDC 70594-049
Product ID 70594-049_fda91987-b6cd-4233-b09c-0f0300ad5df2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202766
Listing Expiration 2026-12-31
Marketing Start 2018-10-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70594049
Hyphenated Format 70594-049

Supplemental Identifiers

RxCUI
204509
UPC
0370594049014
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 (70594-049-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
  • 10 VIAL, GLASS in 1 CARTON (70594-049-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
source: ndc

Packages (2)

70594-049-01 1 VIAL, GLASS in 1 CARTON (70594-049-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS 70594-049-02 10 VIAL, GLASS in 1 CARTON (70594-049-02) / 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": "fda91987-b6cd-4233-b09c-0f0300ad5df2", "openfda": {"upc": ["0370594049014"], "unii": ["19371312D4"], "rxcui": ["204509"], "spl_set_id": ["b56f18c0-ef5e-4ed9-a5af-f79f3cd189b6"], "manufacturer_name": ["Xellia Pharmaceuticals USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (70594-049-01)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS", "package_ndc": "70594-049-01", "marketing_start_date": "20181001"}, {"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (70594-049-02)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS", "package_ndc": "70594-049-02", "marketing_start_date": "20181001"}], "brand_name": "Polymyxin B", "product_id": "70594-049_fda91987-b6cd-4233-b09c-0f0300ad5df2", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "70594-049", "generic_name": "Polymyxin B Sulfate", "labeler_name": "Xellia Pharmaceuticals 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": "ANDA202766", "marketing_category": "ANDA", "marketing_start_date": "20181001", "listing_expiration_date": "20261231"}