neomycin and polymyxin b sulfates

Generic: neomycin and polymyxin b sulfates

Labeler: xgen pharmaceuticals djb, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name neomycin and polymyxin b sulfates
Generic Name neomycin and polymyxin b sulfates
Labeler xgen pharmaceuticals djb, inc.
Dosage Form SOLUTION
Routes
IRRIGATION
Active Ingredients

neomycin sulfate 40 mg/mL, polymyxin b sulfate 200000 [USP'U]/mL

Manufacturer
XGen Pharmaceuticals DJB, Inc.

Identifiers & Regulatory

Product NDC 39822-1201
Product ID 39822-1201_459b4410-1bb0-c1fc-e063-6394a90a08ce
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065106
Listing Expiration 2026-12-31
Marketing Start 2006-01-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 398221201
Hyphenated Format 39822-1201

Supplemental Identifiers

RxCUI
314124
UNII
19371312D4 057Y626693

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 neomycin and polymyxin b sulfates (source: ndc)
Generic Name neomycin and polymyxin b sulfates (source: ndc)
Application Number ANDA065106 (source: ndc)
Routes
IRRIGATION
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
  • 200000 [USP'U]/mL
source: ndc
Packaging
  • 10 AMPULE in 1 CARTON (39822-1201-2) / 1 mL in 1 AMPULE (39822-1201-1)
  • 50 AMPULE in 1 CARTON (39822-1201-5) / 1 mL in 1 AMPULE
source: ndc

Packages (2)

39822-1201-2 10 AMPULE in 1 CARTON (39822-1201-2) / 1 mL in 1 AMPULE (39822-1201-1) 39822-1201-5 50 AMPULE in 1 CARTON (39822-1201-5) / 1 mL in 1 AMPULE

Ingredients (2)

neomycin sulfate (40 mg/mL) polymyxin b sulfate (200000 [USP'U]/mL)

Linked Drug Pages (1)

Neomycin and Polymyxin B Sulfates ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["IRRIGATION"], "spl_id": "459b4410-1bb0-c1fc-e063-6394a90a08ce", "openfda": {"unii": ["19371312D4", "057Y626693"], "rxcui": ["314124"], "spl_set_id": ["a2f47d77-efd3-4c84-a364-08fb6d9978eb"], "manufacturer_name": ["XGen Pharmaceuticals DJB, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 AMPULE in 1 CARTON (39822-1201-2)  / 1 mL in 1 AMPULE (39822-1201-1)", "package_ndc": "39822-1201-2", "marketing_start_date": "20060119"}, {"sample": false, "description": "50 AMPULE in 1 CARTON (39822-1201-5)  / 1 mL in 1 AMPULE", "package_ndc": "39822-1201-5", "marketing_start_date": "20060119"}], "brand_name": "Neomycin and Polymyxin B Sulfates", "product_id": "39822-1201_459b4410-1bb0-c1fc-e063-6394a90a08ce", "dosage_form": "SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "39822-1201", "generic_name": "Neomycin and Polymyxin B Sulfates", "labeler_name": "XGen Pharmaceuticals DJB, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Neomycin and Polymyxin B Sulfates", "active_ingredients": [{"name": "NEOMYCIN SULFATE", "strength": "40 mg/mL"}, {"name": "POLYMYXIN B SULFATE", "strength": "200000 [USP'U]/mL"}], "application_number": "ANDA065106", "marketing_category": "ANDA", "marketing_start_date": "20060119", "listing_expiration_date": "20261231"}