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United States · US · US:68788-6927_dd68b337-2566-4dbe-a10a-53fe12507557

Polymyxin B Sulfate and Trimethoprim

Orange BookUNIISPLATC A07AA

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

Identification

ManufacturerPreferred Pharmacetucials Inc.
CountryUS (United States)
ATC codeA07AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6878869271
    10 mL in 1 BOTTLE, PLASTIC (68788-6927-1)

Annotations

UNII (FDA Substance ID)
19371312D4
POLYMYXIN B SULFATE
RxCUI 388
Orange Book
A064211
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "19371312D4",
    "rxcui": "388",
    "inchikey": null,
    "display_name": "POLYMYXIN B SULFATE",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "31a7ad1f-3f58-41a0-94f0-36674285bb61": {
      "match": "brand_token",
      "title": "POLYMYXIN B SULFATE AND TRIMETHOPRIM (POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS INC.]",
      "spl_version": "5",
      "published_date": "2026-03-04"
    }
  },
  "productid": "68788-6927_dd68b337-2566-4dbe-a10a-53fe12507557",
  "productndc": "68788-6927",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "064211",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AT",
        "strength": "10,000 UNITS/ML;EQ 1MG BASE/ML",
        "product_no": "001",
        "approval_date": "Apr 13, 1998"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE",
  "proprietary_name": "Polymyxin B Sulfate and Trimethoprim",
  "active_ingred_unit": "[USP'U]/mL; mg/mL",
  "application_number": "ANDA064211",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Polymyxin B Sulfate and Trimethoprim",
  "start_marketing_date": "20180330",
  "active_numerator_strength": "10000; 1"
}

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