🇺🇸
United States · US · US:63187-008_2dd0e8d4-6ac3-433f-a41f-1e55d2b3f5ca
Sulfamethoxazole and Trimethoprim
Orange BookUNIISPLATC J01EC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeJ01EC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc1163187008066 TABLET in 1 BOTTLE (63187-008-06)
- ndc11631870081010 TABLET in 1 BOTTLE (63187-008-10)
- ndc11631870081414 TABLET in 1 BOTTLE (63187-008-14)
- ndc11631870082020 TABLET in 1 BOTTLE (63187-008-20)
- ndc11631870082828 TABLET in 1 BOTTLE (63187-008-28)
- ndc11631870084040 TABLET in 1 BOTTLE (63187-008-40)
Annotations
UNII (FDA Substance ID)
JE42381TNV
SULFAMETHOXAZOLE
RxCUI 10180
Orange Book
A076817
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": "63187-008_2dd0e8d4-6ac3-433f-a41f-1e55d2b3f5ca",
"productndc": "63187-008",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076817",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG;80MG",
"product_no": "001",
"approval_date": "Oct 7, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "800MG;160MG",
"product_no": "002",
"approval_date": "Oct 7, 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": "ANDA076817",
"marketing_category": "ANDA",
"nonproprietary_name": "Sulfamethoxazole and Trimethoprim",
"start_marketing_date": "20060822",
"active_numerator_strength": "800; 160"
}Related drugs
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- 🇺🇸Sulfameth/Trimeth-DSDirect_Rx
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