🇺🇸
United States · US · US:70954-258_3c60334c-7cf5-4946-9fcf-e01c1dcff9e0
Sulfamethoxazole and Trimethoprim
Orange BookUNIISPLATC J01EC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ01EC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117095425810473 mL in 1 BOTTLE (70954-258-10)
Annotations
UNII (FDA Substance ID)
JE42381TNV
SULFAMETHOXAZOLE
RxCUI 10180
Orange Book
A214330
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": "70954-258_3c60334c-7cf5-4946-9fcf-e01c1dcff9e0",
"productndc": "70954-258",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "214330",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG/5ML;40MG/5ML",
"product_no": "001",
"approval_date": "Feb 8, 2022"
}
],
"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": "ANDA214330",
"marketing_category": "ANDA",
"nonproprietary_name": "Sulfamethoxazole and Trimethoprim",
"start_marketing_date": "20220208",
"active_numerator_strength": "200; 40"
}Related drugs
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- 🇺🇸Sulfameth/Trimeth-DSDirect_Rx
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