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United States · US · US:63629-1765_a903d079-327d-475b-953f-045f458657e5

Sulfamethoxazole and Trimethoprim

Orange BookUNIISPLATC J01EC

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeJ01EC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 10

  • ndc11
    6362917650
    21 TABLET in 1 BOTTLE (63629-1765-0)
  • ndc11
    6362917651
    20 TABLET in 1 BOTTLE (63629-1765-1)
  • ndc11
    6362917652
    14 TABLET in 1 BOTTLE (63629-1765-2)
  • ndc11
    6362917653
    10 TABLET in 1 BOTTLE (63629-1765-3)
  • ndc11
    6362917654
    28 TABLET in 1 BOTTLE (63629-1765-4)
  • ndc11
    6362917655
    40 TABLET in 1 BOTTLE (63629-1765-5)
  • ndc11
    6362917656
    6 TABLET in 1 BOTTLE (63629-1765-6)
  • ndc11
    6362917657
    60 TABLET in 1 BOTTLE (63629-1765-7)
  • ndc11
    6362917658
    30 TABLET in 1 BOTTLE (63629-1765-8)
  • ndc11
    6362917659
    13 TABLET in 1 BOTTLE (63629-1765-9)

Annotations

UNII (FDA Substance ID)
JE42381TNV
SULFAMETHOXAZOLE
RxCUI 10180
Orange Book
A076899
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": "63629-1765_a903d079-327d-475b-953f-045f458657e5",
  "productndc": "63629-1765",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076899",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG;80MG",
        "product_no": "001",
        "approval_date": "Jan 27, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG;160MG",
        "product_no": "002",
        "approval_date": "Jan 27, 2005"
      }
    ],
    "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": "ANDA076899",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sulfamethoxazole and Trimethoprim",
  "start_marketing_date": "20100913",
  "active_numerator_strength": "800; 160"
}

Related drugs

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