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United States · US · US:61919-645_47e154aa-d636-469b-e063-6394a90ad9b9

Sulfameth/Trimeth-DS

Orange BookUNIISPLATC J01EC

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

Identification

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

Packs · 4

  • ndc11
    6191964506
    6 TABLET in 1 BOTTLE (61919-645-06)
  • ndc11
    6191964530
    30 TABLET in 1 BOTTLE (61919-645-30)
  • ndc11
    6191964556
    56 TABLET in 1 BOTTLE (61919-645-56)
  • ndc11
    6191964560
    60 TABLET in 1 BOTTLE (61919-645-60)

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": {
    "90026ce8-3305-6272-e053-2995a90a57e0": {
      "match": "brand_token",
      "title": "SULFAMETH/TRIMETH-DS TABLET [DIRECT_RX]",
      "spl_version": "7",
      "published_date": "2026-01-09"
    }
  },
  "productid": "61919-645_47e154aa-d636-469b-e063-6394a90ad9b9",
  "productndc": "61919-645",
  "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": "Sulfameth/Trimeth-DS",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA090624",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sulfameth/Trimeth-DS",
  "start_marketing_date": "20190813",
  "active_numerator_strength": "800; 160"
}

Related drugs

Other records sharing ATC code J01EC.

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