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United States · US · US:85766-015_49ef26b9-b7b9-bfa8-e063-6394a90a0c50

Sulfamethoxazole and Trimethoprim

Orange BookUNIISPLATC J01EC

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

Identification

ManufacturerSportpharm LLC
CountryUS (United States)
ATC codeJ01EC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 8

  • ndc11
    8576601501
    100 TABLET in 1 BOTTLE (85766-015-01)
  • ndc11
    8576601505
    500 TABLET in 1 BOTTLE (85766-015-05)
  • ndc11
    8576601506
    6 TABLET in 1 BOTTLE (85766-015-06)
  • ndc11
    8576601510
    10 TABLET in 1 BOTTLE (85766-015-10)
  • ndc11
    8576601514
    14 TABLET in 1 BOTTLE (85766-015-14)
  • ndc11
    8576601520
    20 TABLET in 1 BOTTLE (85766-015-20)
  • ndc11
    8576601528
    28 TABLET in 1 BOTTLE (85766-015-28)
  • ndc11
    8576601530
    30 TABLET in 1 BOTTLE (85766-015-30)

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": "85766-015_49ef26b9-b7b9-bfa8-e063-6394a90a0c50",
  "productndc": "85766-015",
  "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": "20100216",
  "active_numerator_strength": "800; 160"
}

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