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United States · US · US:66267-196_1fa6a784-9fb2-c3fa-e063-6394a90add4c

Sulfamethoxazole and Trimethoprim

Orange BookUNIISPLATC J01EC

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

Identification

ManufacturerNuCare Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ01EC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 8

  • ndc11
    6626719606
    6 TABLET in 1 BOTTLE (66267-196-06)
  • ndc11
    6626719610
    10 TABLET in 1 BOTTLE (66267-196-10)
  • ndc11
    6626719614
    14 TABLET in 1 BOTTLE (66267-196-14)
  • ndc11
    6626719620
    20 TABLET in 1 BOTTLE (66267-196-20)
  • ndc11
    6626719628
    28 TABLET in 1 BOTTLE (66267-196-28)
  • ndc11
    6626719630
    30 TABLET in 1 BOTTLE (66267-196-30)
  • ndc11
    6626719660
    60 TABLET in 1 BOTTLE (66267-196-60)
  • ndc11
    6626719690
    90 TABLET in 1 BOTTLE (66267-196-90)

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": "66267-196_1fa6a784-9fb2-c3fa-e063-6394a90add4c",
  "productndc": "66267-196",
  "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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