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United States · US · US:68788-7345_5b51ac80-49b2-4027-a374-fc78a0e28bbf

SULFATRIM

Orange BookUNIISPLATC J01EC

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

Identification

ManufacturerPreferred Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ01EC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6878873454
    473 mL in 1 BOTTLE (68788-7345-4)

Annotations

UNII (FDA Substance ID)
JE42381TNV
SULFAMETHOXAZOLE
RxCUI 10180
Orange Book
N018615
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "JE42381TNV",
    "rxcui": "10180",
    "inchikey": "JLKIGFTWXXRPMT-UHFFFAOYSA-N",
    "display_name": "SULFAMETHOXAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "80f7f00b-add4-4d6b-9e9c-bea29768c239": {
      "match": "brand_token",
      "title": "SULFATRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) SUSPENSION [A-S MEDICATION SOLUTIONS]",
      "spl_version": "2",
      "published_date": "2026-01-06"
    }
  },
  "productid": "68788-7345_5b51ac80-49b2-4027-a374-fc78a0e28bbf",
  "productndc": "68788-7345",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "018615",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG/5ML;40MG/5ML",
        "product_no": "001",
        "approval_date": "Jan 7, 1983"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG/5ML;40MG/5ML",
        "product_no": "002",
        "approval_date": "Jan 7, 1983"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
  "proprietary_name": "SULFATRIM",
  "active_ingred_unit": "mg/5mL; mg/5mL",
  "application_number": "NDA018615",
  "marketing_category": "NDA",
  "nonproprietary_name": "Sulfamethoxazole and Trimethoprim",
  "start_marketing_date": "20200601",
  "active_numerator_strength": "200; 40"
}

Related drugs

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