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United States · US · US:24208-830_22348d2e-ed9a-bb62-e063-6394a90aa6df

Neomycin Polymyxin B Sulfates and Dexamethasone

Orange BookUNIISPLATC A01AC

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

Identification

ManufacturerBausch & Lomb Incorporated
CountryUS (United States)
ATC codeA01AC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2420883060
    1 BOTTLE, DROPPER in 1 CARTON (24208-830-60) / 5 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
7S5I7G3JQL
DEXAMETHASONE
RxCUI 3264
Orange Book
A064135
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7S5I7G3JQL",
    "rxcui": "3264",
    "inchikey": "UREBDLICKHMUKA-CXSFZGCWSA-N",
    "display_name": "DEXAMETHASONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "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": "24208-830_22348d2e-ed9a-bb62-e063-6394a90aa6df",
  "productndc": "24208-830",
  "dosage_form": "SUSPENSION/ DROPS",
  "orange_book": {
    "appl_no": "064135",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML",
        "product_no": "001",
        "approval_date": "Sep 13, 1995"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
  "proprietary_name": "Neomycin Polymyxin B Sulfates and Dexamethasone",
  "active_ingred_unit": "mg/mL; mg/mL; [USP'U]/mL",
  "application_number": "ANDA064135",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone",
  "start_marketing_date": "19950913",
  "active_numerator_strength": "1; 3.5; 10000"
}

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