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United States · US · US:63187-193_a0deddd4-f2c7-4594-ac0d-1ed4ce48b891

Trimethoprim sulfate and Polymyxin B sulfate

Orange BookUNIISPLATC A07AA

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeA07AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6318719310
    1 BOTTLE, DROPPER in 1 CARTON (63187-193-10) / 10 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
19371312D4
POLYMYXIN B SULFATE
RxCUI 388
Orange Book
A065006
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": {
    "249e938d-f181-47c4-a082-372d65462f33": {
      "match": "brand_token",
      "title": "TRIMETHOPRIM TABLET [LUPIN PHARMACEUTICALS,INC.]",
      "spl_version": "6",
      "published_date": "2024-12-04"
    }
  },
  "productid": "63187-193_a0deddd4-f2c7-4594-ac0d-1ed4ce48b891",
  "productndc": "63187-193",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "065006",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "10,000 UNITS/ML;EQ 1MG BASE/ML",
        "product_no": "001",
        "approval_date": "Dec 17, 1998"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE",
  "proprietary_name": "Trimethoprim sulfate and Polymyxin B sulfate",
  "active_ingred_unit": "[USP'U]/mL; mg/mL",
  "application_number": "ANDA065006",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Trimethoprim sulfate and Polymyxin B sulfate",
  "start_marketing_date": "19981217",
  "active_numerator_strength": "10000; 1"
}

Related drugs

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