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United States · US · US:0121-0854_a13ce54e-96e8-437a-b4f7-0af852a5a10a
SULFATRIM
Orange BookUNIISPLATC J01EC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPAI Holdings, LLC dba PAI Pharma
CountryUS (United States)
ATC codeJ01EC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110121085416473 mL in 1 BOTTLE (0121-0854-16)
Annotations
UNII (FDA Substance ID)
JE42381TNV
SULFAMETHOXAZOLE
RxCUI 10180
Orange Book
N018615
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": {
"80f7f00b-add4-4d6b-9e9c-bea29768c239": {
"match": "brand_token",
"title": "SULFATRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) SUSPENSION [A-S MEDICATION SOLUTIONS]",
"spl_version": "2",
"published_date": "2026-01-06"
}
},
"productid": "0121-0854_a13ce54e-96e8-437a-b4f7-0af852a5a10a",
"productndc": "0121-0854",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "018615",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG/5ML;40MG/5ML",
"product_no": "001",
"approval_date": "Jan 7, 1983"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "200MG/5ML;40MG/5ML",
"product_no": "002",
"approval_date": "Jan 7, 1983"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"proprietary_name": "SULFATRIM",
"active_ingred_unit": "mg/5mL; mg/5mL",
"application_number": "NDA018615",
"marketing_category": "NDA",
"nonproprietary_name": "Sulfamethoxazole and Trimethoprim",
"start_marketing_date": "19830703",
"active_numerator_strength": "200; 40"
}Related drugs
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- 🇺🇸Sulfameth/Trimeth-DSDirect_Rx
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