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United States · US · US:17856-0496_361f7b6e-a67d-c21a-e063-6394a90ad8ba

Sulfamethoxazole and Trimethoprim

Orange BookUNIISPLATC J01EC

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

Identification

ManufacturerATLANTIC BIOLOGICALS CORP.
CountryUS (United States)
ATC codeJ01EC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    1785604964
    72 CUP, UNIT-DOSE in 1 BOX (17856-0496-4) / 5 mL in 1 CUP, UNIT-DOSE (17856-0496-1)
  • ndc11
    1785604965
    50 CUP, UNIT-DOSE in 1 BOX (17856-0496-5) / 20 mL in 1 CUP, UNIT-DOSE (17856-0496-3)
  • ndc11
    1785604966
    72 CUP, UNIT-DOSE in 1 BOX (17856-0496-6) / 10 mL in 1 CUP, UNIT-DOSE (17856-0496-2)

Annotations

UNII (FDA Substance ID)
JE42381TNV
SULFAMETHOXAZOLE
RxCUI 10180
Orange Book
A091348
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": {
    "518cc045-a12b-f08f-e063-6394a90acb0c": {
      "match": "brand_token",
      "title": "SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [COUPLER LLC]",
      "spl_version": "1",
      "published_date": "2026-05-13"
    }
  },
  "productid": "17856-0496_361f7b6e-a67d-c21a-e063-6394a90ad8ba",
  "productndc": "17856-0496",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "091348",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG/5ML;40MG/5ML",
        "product_no": "001",
        "approval_date": "Jun 8, 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/5mL; mg/5mL",
  "application_number": "ANDA091348",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sulfamethoxazole and Trimethoprim",
  "start_marketing_date": "20171004",
  "active_numerator_strength": "200; 40"
}

Related drugs

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