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United States · US · US:0615-8121_18da7fe1-4328-4868-9e5f-65e7d3dde75d

Sulfamethoxazole and Trimethoprim

Orange BookUNIISPLATC J01EC

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

Identification

ManufacturerNCS HealthCare of KY, LLC dba Vangard Labs
CountryUS (United States)
ATC codeJ01EC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    0615812110
    10 TABLET in 1 BLISTER PACK (0615-8121-10)
  • ndc11
    0615812114
    14 TABLET in 1 BLISTER PACK (0615-8121-14)
  • ndc11
    0615812120
    20 TABLET in 1 BLISTER PACK (0615-8121-20)
  • ndc11
    0615812139
    30 TABLET in 1 BLISTER PACK (0615-8121-39)

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": "0615-8121_18da7fe1-4328-4868-9e5f-65e7d3dde75d",
  "productndc": "0615-8121",
  "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"
}

Related drugs

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