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United States · US · US:60429-259_36efef59-2b05-db1b-e063-6394a90af8ea

Sulfamethoxazole and Trimethoprim

Orange BookUNIISPLATC J01EC

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

Identification

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

Packs · 1

  • ndc11
    6042925901
    100 TABLET in 1 BOTTLE, PLASTIC (60429-259-01)

Annotations

UNII (FDA Substance ID)
JE42381TNV
SULFAMETHOXAZOLE
RxCUI 10180
Orange Book
A071017
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": "60429-259_36efef59-2b05-db1b-e063-6394a90af8ea",
  "productndc": "60429-259",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "071017",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG;160MG",
        "product_no": "001",
        "approval_date": "Aug 25, 1986"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG;80MG",
        "product_no": "002",
        "approval_date": "Aug 25, 1986"
      }
    ],
    "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": "ANDA071017",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sulfamethoxazole and Trimethoprim",
  "start_marketing_date": "19860825",
  "active_numerator_strength": "800; 160"
}

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