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United States · US · US:24208-315_4732077c-74ed-5e9a-e063-6294a90a6315

Polymyxin B Sulfate and Trimethoprim

Orange BookUNIISPLATC A07AA

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

Identification

ManufacturerBausch & Lomb Incorporated
CountryUS (United States)
ATC codeA07AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2420831510
    1 BOTTLE, DROPPER in 1 CARTON (24208-315-10) / 10 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
19371312D4
POLYMYXIN B SULFATE
RxCUI 388
Orange Book
A064120
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": "24208-315_4732077c-74ed-5e9a-e063-6294a90a6315",
  "productndc": "24208-315",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "064120",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "10,000 UNITS/ML;EQ 1MG BASE/ML",
        "product_no": "001",
        "approval_date": "Feb 14, 1997"
      }
    ],
    "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": "ANDA064120",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Polymyxin B Sulfate and Trimethoprim Sulfate",
  "start_marketing_date": "19970214",
  "active_numerator_strength": "10000; 1"
}

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