🇺🇸
United States · US · US:65162-272_fd58f01a-3607-4f18-97e3-f695bcb32ad5
Sulfamethoxazole and Trimethoprim
Orange BookUNIISPLATC J01EC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeJ01EC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11651622720110 TABLET in 1 BOTTLE (65162-272-01)
- ndc116516227210100 TABLET in 1 BOTTLE (65162-272-10)
- ndc11651622722424 TABLET in 1 BOTTLE (65162-272-24)
- ndc116516227225250 TABLET in 1 BOTTLE (65162-272-25)
- ndc116516227250500 TABLET in 1 BOTTLE (65162-272-50)
Annotations
UNII (FDA Substance ID)
JE42381TNV
SULFAMETHOXAZOLE
RxCUI 10180
Orange Book
A076899
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": "65162-272_fd58f01a-3607-4f18-97e3-f695bcb32ad5",
"productndc": "65162-272",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076899",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG;80MG",
"product_no": "001",
"approval_date": "Jan 27, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "800MG;160MG",
"product_no": "002",
"approval_date": "Jan 27, 2005"
}
],
"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": "ANDA076899",
"marketing_category": "ANDA",
"nonproprietary_name": "Sulfamethoxazole and Trimethoprim",
"start_marketing_date": "20100913",
"active_numerator_strength": "800; 160"
}Related drugs
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- 🇺🇸Sulfameth/Trimeth-DSDirect_Rx
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