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United States · US · US:50090-7836_582e04ab-98bc-46c8-8e39-ccd2dccd4c2b

SULFATRIM

Orange BookUNIISPLATC J01EC

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeJ01EC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009078360
    473 mL in 1 BOTTLE (50090-7836-0)

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": "50090-7836_582e04ab-98bc-46c8-8e39-ccd2dccd4c2b",
  "productndc": "50090-7836",
  "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": "19830703",
  "active_numerator_strength": "200; 40"
}

Related drugs

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