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United States · US · US:49708-146_2a76a544-1f84-4b42-e063-6394a90a08d5
Bactrim DS
Orange BookUNIISPLATC J01EC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc
CountryUS (United States)
ATC codeJ01EC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc114970814601100 TABLET in 1 BOTTLE, PLASTIC (49708-146-01)
Annotations
UNII (FDA Substance ID)
JE42381TNV
SULFAMETHOXAZOLE
RxCUI 10180
Orange Book
N017377
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": {
"f59d0c04-9c66-4d53-a0e1-cb55570deb62": {
"match": "brand_token",
"title": "BACTRIM DS (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET BACTRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC]",
"spl_version": "18",
"published_date": "2025-01-01"
}
},
"productid": "49708-146_2a76a544-1f84-4b42-e063-6394a90a08d5",
"productndc": "49708-146",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "017377",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "400MG;80MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "800MG;160MG",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"proprietary_name": "Bactrim DS",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA017377",
"marketing_category": "NDA",
"nonproprietary_name": "sulfamethoxazole and Trimethoprim",
"start_marketing_date": "20041101",
"active_numerator_strength": "800; 160"
}Related drugs
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