🇺🇸
United States · US · US:66993-727_cc7ce9be-e89e-4682-8d14-0902ba36b47a
Sulfamethoxazole and Trimethoprim
Orange BookUNIISPLATC J01EC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPrasco Laboratories
CountryUS (United States)
ATC codeJ01EC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116699372757473 mL in 1 BOTTLE, PLASTIC (66993-727-57)
Annotations
UNII (FDA Substance ID)
JE42381TNV
SULFAMETHOXAZOLE
RxCUI 10180
Orange Book
A077612
AB
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": "66993-727_cc7ce9be-e89e-4682-8d14-0902ba36b47a",
"productndc": "66993-727",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "077612",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "Nov 13, 2006"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"proprietary_name": "Sulfamethoxazole and Trimethoprim",
"active_ingred_unit": "mg/5mL; mg/5mL",
"application_number": "ANDA077612",
"marketing_category": "ANDA",
"nonproprietary_name": "sulfamethoxazole and trimethoprim",
"start_marketing_date": "20220705",
"active_numerator_strength": "200; 40"
}Related drugs
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- 🇺🇸Sulfameth/Trimeth-DSDirect_Rx
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