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United States · US · US:39822-1220_4d508cf6-f6a4-be9f-e063-6394a90af91e

Neomycin and Polymyxin B Sulfates

Orange BookUNIISPLATC A01AB

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerXGen Pharmaceuticals DJB, Inc.
CountryUS (United States)
ATC codeA01AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3982212201
    1 VIAL, GLASS in 1 CARTON (39822-1220-1) / 20 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
057Y626693
NEOMYCIN SULFATE
RxCUI 7300
Orange Book
A065108
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "057Y626693",
    "rxcui": "7300",
    "inchikey": null,
    "display_name": "NEOMYCIN SULFATE",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "IRRIGATION",
  "spl_meta": {
    "a2f47d77-efd3-4c84-a364-08fb6d9978eb": {
      "match": "brand_token",
      "title": "NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION [XGEN PHARMACEUTICALS DJB, INC.]",
      "spl_version": "18",
      "published_date": "2026-05-21"
    }
  },
  "productid": "39822-1220_4d508cf6-f6a4-be9f-e063-6394a90af91e",
  "productndc": "39822-1220",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "065108",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "EQ 40MG BASE/ML;200,000 UNITS/ML",
        "product_no": "001",
        "approval_date": "Jan 31, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
  "proprietary_name": "Neomycin and Polymyxin B Sulfates",
  "active_ingred_unit": "mg/mL; [USP'U]/mL",
  "application_number": "ANDA065108",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Neomycin and Polymyxin B Sulfates",
  "start_marketing_date": "20060131",
  "active_numerator_strength": "40; 200000"
}

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