🇺🇸
United States · US · US:68071-4948_47acdd43-4e46-66bc-e063-6394a90a9c04
Sulfamethoxazole and Trimethoprim
Orange BookUNIISPLATC J01EC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNuCare Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeJ01EC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1168071494822 TABLET in 1 BOTTLE (68071-4948-2)
- ndc1168071494844 TABLET in 1 BOTTLE (68071-4948-4)
- ndc1168071494866 TABLET in 1 BOTTLE (68071-4948-6)
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": "68071-4948_47acdd43-4e46-66bc-e063-6394a90a9c04",
"productndc": "68071-4948",
"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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