🇺🇸
United States · US · US:72789-064_3403cd92-3140-e0c6-e063-6294a90a5a1c
Sulfamethoxazole and Trimethoprim
Orange BookUNIISPLATC J01EC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ01EC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1172789064066 TABLET in 1 BOTTLE, PLASTIC (72789-064-06)
- ndc11727890641414 TABLET in 1 BOTTLE, PLASTIC (72789-064-14)
- ndc11727890642020 TABLET in 1 BOTTLE, PLASTIC (72789-064-20)
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": "72789-064_3403cd92-3140-e0c6-e063-6294a90a5a1c",
"productndc": "72789-064",
"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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