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United States · US · US:72189-532_0ec1dfdf-b640-fb0c-e063-6294a90a843d

Neo/Poly-B/Dex Ophth Oint

Orange BookUNIISPLATC A01AC

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

Identification

ManufacturerDirect_Rx
CountryUS (United States)
ATC codeA01AC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7218953235
    3.5 g in 1 BOTTLE (72189-532-35)

Annotations

UNII (FDA Substance ID)
7S5I7G3JQL
DEXAMETHASONE
RxCUI 3264
Orange Book
A064063
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": {
    "0ec1dfdf-b63f-fb0c-e063-6294a90a843d": {
      "match": "brand_token",
      "title": "NEO/POLY-B/DEX OPHTH OINT OINTMENT [DIRECT_RX]",
      "spl_version": "1",
      "published_date": "2024-01-16"
    }
  },
  "productid": "72189-532_0ec1dfdf-b640-fb0c-e063-6294a90a843d",
  "productndc": "72189-532",
  "dosage_form": "OINTMENT",
  "orange_book": {
    "appl_no": "064063",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM",
        "product_no": "001",
        "approval_date": "Jul 25, 1994"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
  "proprietary_name": "Neo/Poly-B/Dex Ophth Oint",
  "active_ingred_unit": "mg/g; mg/g; [USP'U]/g",
  "application_number": "ANDA064063",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Neo/Poly-B/Dex Ophth Oint",
  "start_marketing_date": "20240112",
  "active_numerator_strength": "1; 3.5; 10000"
}

Related drugs

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