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United States · US · US:68071-5267_2a849ae9-3395-4642-e063-6394a90a1ca4

Bacitracin Zinc and Polymyxin B Sulfate

In shortageOrange BookUNIISPLATC D06AX

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

Identification

ManufacturerNuCare Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeD06AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6807152673
    3.5 g in 1 BOX (68071-5267-3)

Annotations

UNII (FDA Substance ID)
89Y4M234ES
BACITRACIN ZINC
RxCUI 11417
Orange Book
A064046
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Bacitracin Ophthalmic Ointment
Raw payload (JSON)
{
  "unii": {
    "unii": "89Y4M234ES",
    "rxcui": "11417",
    "inchikey": null,
    "display_name": "BACITRACIN ZINC",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "3f0eb4a0-f7bf-45f7-8885-92c65a4bd899": {
      "match": "brand_token",
      "title": "BACITRACIN OINTMENT [ALDERMED INC.]",
      "spl_version": "5",
      "published_date": "2026-05-11"
    }
  },
  "productid": "68071-5267_2a849ae9-3395-4642-e063-6394a90a1ca4",
  "productndc": "68071-5267",
  "dosage_form": "OINTMENT",
  "orange_book": {
    "appl_no": "064046",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "500 UNITS/GM;10,000 UNITS/GM",
        "product_no": "001",
        "approval_date": "Jan 26, 1995"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BACITRACIN ZINC; POLYMYXIN B SULFATE",
  "shortage_reason": "Bacitracin Ophthalmic Ointment",
  "shortage_status": "current",
  "proprietary_name": "Bacitracin Zinc and Polymyxin B Sulfate",
  "active_ingred_unit": "[USP'U]/g; [USP'U]/g",
  "application_number": "ANDA064046",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bacitracin Zinc and Polymyxin B Sulfate",
  "start_marketing_date": "20080425",
  "active_numerator_strength": "500; 10000"
}

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