Back to search
🇺🇸

United States · US · US:54348-625_ea935f93-6c2d-2e8a-e053-2995a90a2ce0

Sulfamethox-TMP DS

Orange BookUNIIATC J01EC

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

Identification

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

Packs · 4

  • ndc11
    5434862506
    1 BOTTLE in 1 BOX (54348-625-06) / 6 TABLET in 1 BOTTLE
  • ndc11
    5434862510
    1 BOTTLE in 1 BOX (54348-625-10) / 10 TABLET in 1 BOTTLE
  • ndc11
    5434862514
    1 BOTTLE in 1 BOX (54348-625-14) / 14 TABLET in 1 BOTTLE
  • ndc11
    5434862520
    1 BOTTLE in 1 BOX (54348-625-20) / 20 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
JE42381TNV
SULFAMETHOXAZOLE
RxCUI 10180
Orange Book
A076899
ABAB
Raw payload (JSON)
{
  "unii": {
    "unii": "JE42381TNV",
    "rxcui": "10180",
    "inchikey": "JLKIGFTWXXRPMT-UHFFFAOYSA-N",
    "display_name": "SULFAMETHOXAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "productid": "54348-625_ea935f93-6c2d-2e8a-e053-2995a90a2ce0",
  "productndc": "54348-625",
  "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": "Sulfamethox-TMP DS",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA076899",
  "marketing_category": "ANDA",
  "nonproprietary_name": "SULFAMETHOXAZOLE, TRIMETHOPRIM",
  "start_marketing_date": "20190711",
  "active_numerator_strength": "800; 160"
}

Related drugs

Other records sharing ATC code J01EC.

Access this data programmatically

Query Sulfamethox-TMP DS and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.