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United States · US · US:70518-2604_4a6a1c66-916a-8ea9-e063-6394a90aa480

Sulfamethoxazole and Trimethoprim

Orange BookUNIISPLATC J01EC

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

Identification

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

Packs · 7

  • ndc11
    7051826042
    6 TABLET in 1 BOTTLE, PLASTIC (70518-2604-2)
  • ndc11
    7051826043
    14 TABLET in 1 BLISTER PACK (70518-2604-3)
  • ndc11
    7051826044
    20 TABLET in 1 BOTTLE, PLASTIC (70518-2604-4)
  • ndc11
    7051826045
    30 TABLET in 1 BLISTER PACK (70518-2604-5)
  • ndc11
    7051826046
    20 TABLET in 1 BLISTER PACK (70518-2604-6)
  • ndc11
    7051826048
    14 TABLET in 1 BOTTLE, PLASTIC (70518-2604-8)
  • ndc11
    7051826049
    10 TABLET in 1 BOTTLE, PLASTIC (70518-2604-9)

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": "70518-2604_4a6a1c66-916a-8ea9-e063-6394a90aa480",
  "productndc": "70518-2604",
  "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": "20200228",
  "active_numerator_strength": "800; 160"
}

Related drugs

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