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United States · US · US:67296-1657_1dfcbde9-641f-7454-e063-6394a90ad1e9

SULFATRIM

Orange BookUNIISPLATC J01EC

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

Identification

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

Packs · 2

  • ndc11
    6729616571
    100 mL in 1 BOTTLE (67296-1657-1)
  • ndc11
    6729616572
    200 mL in 1 BOTTLE (67296-1657-2)

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": "67296-1657_1dfcbde9-641f-7454-e063-6394a90ad1e9",
  "productndc": "67296-1657",
  "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": "19830701",
  "active_numerator_strength": "200; 40"
}

Related drugs

Other records sharing ATC code J01EC.

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