Sulfamethoxazole and Trimethoprim

Orange BookUNIISPLATC J01EC

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerCardinal Health 107, LLC

CountryUS (United States)

ATC codeJ01EC

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5515425800
10 BLISTER PACK in 1 BAG (55154-2580-0) / 1 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

JE42381TNV

SULFAMETHOXAZOLE

RxCUI 10180

Orange Book

A090624

ABAB

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": {
    "518cc045-a12b-f08f-e063-6394a90acb0c": {
      "match": "brand_token",
      "title": "SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [COUPLER LLC]",
      "spl_version": "1",
      "published_date": "2026-05-13"
    }
  },
  "productid": "55154-2580_08500fcb-dbec-4ac2-91c3-189d27907ec0",
  "productndc": "55154-2580",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090624",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG;80MG",
        "product_no": "001",
        "approval_date": "Feb 16, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG;160MG",
        "product_no": "002",
        "approval_date": "Feb 16, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
  "proprietary_name": "Sulfamethoxazole and Trimethoprim",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA090624",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sulfamethoxazole and Trimethoprim",
  "start_marketing_date": "20260323",
  "active_numerator_strength": "800; 160"
}

Related drugs

Other records sharing ATC code J01EC.

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