polymyxin b

Generic: polymyxin b sulfate

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name polymyxin b
Generic Name polymyxin b sulfate
Labeler gland pharma limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR INTRATHECAL INTRAVENOUS OPHTHALMIC
Active Ingredients

polymyxin b sulfate 500000 [USP'U]/1

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-174
Product ID 68083-174_0f89d7be-ad20-46d1-8cce-0cee8ee572cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207322
Listing Expiration 2026-12-31
Marketing Start 2016-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083174
Hyphenated Format 68083-174

Supplemental Identifiers

RxCUI
204509
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 ANDA207322 (source: ndc)
Routes
INTRAMUSCULAR INTRATHECAL INTRAVENOUS OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 500000 [USP'U]/1
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (68083-174-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (68083-174-01)
source: ndc

Packages (1)

68083-174-10 10 VIAL in 1 CARTON (68083-174-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (68083-174-01)

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": "0f89d7be-ad20-46d1-8cce-0cee8ee572cf", "openfda": {"unii": ["19371312D4"], "rxcui": ["204509"], "spl_set_id": ["dc74dee2-1d0b-4fab-a29b-1755fdb5da75"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (68083-174-10)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (68083-174-01)", "package_ndc": "68083-174-10", "marketing_start_date": "20160601"}], "brand_name": "POLYMYXIN B", "product_id": "68083-174_0f89d7be-ad20-46d1-8cce-0cee8ee572cf", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "68083-174", "generic_name": "POLYMYXIN B SULFATE", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "POLYMYXIN B", "active_ingredients": [{"name": "POLYMYXIN B SULFATE", "strength": "500000 [USP'U]/1"}], "application_number": "ANDA207322", "marketing_category": "ANDA", "marketing_start_date": "20160601", "listing_expiration_date": "20261231"}