🇺🇸
United States · US · US:65862-496_49649c1f-a45f-446e-91ef-f1ebf9090363
Sulfamethoxazole and Trimethoprim
Orange BookUNIISPLATC J01EC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeJ01EC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116586249601100 mL in 1 BOTTLE (65862-496-01)
- ndc116586249647473 mL in 1 BOTTLE (65862-496-47)
- ndc11658624965050 mL in 1 BOTTLE (65862-496-50)
Annotations
UNII (FDA Substance ID)
JE42381TNV
SULFAMETHOXAZOLE
RxCUI 10180
Orange Book
A091348
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": "65862-496_49649c1f-a45f-446e-91ef-f1ebf9090363",
"productndc": "65862-496",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "091348",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "200MG/5ML;40MG/5ML",
"product_no": "001",
"approval_date": "Jun 8, 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/5mL; mg/5mL",
"application_number": "ANDA091348",
"marketing_category": "ANDA",
"nonproprietary_name": "Sulfamethoxazole and Trimethoprim",
"start_marketing_date": "20100608",
"active_numerator_strength": "200; 40"
}Related drugs
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- 🇺🇸Sulfameth/Trimeth-DSDirect_Rx
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