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United States · US · US:49708-145_2a76a544-1f84-4b42-e063-6394a90a08d5

Bactrim

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

  • ndc11
    4970814501
    100 TABLET in 1 BOTTLE, PLASTIC (49708-145-01)

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": "49708-145_2a76a544-1f84-4b42-e063-6394a90a08d5",
  "productndc": "49708-145",
  "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",
  "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": "400; 80"
}

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