Trimethoprim

Orange BookUNIISPLATC J01EA01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerLupin Pharmaceuticals,Inc.

CountryUS (United States)

ATC codeJ01EA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4338633001
100 TABLET in 1 BOTTLE (43386-330-01)

Annotations

UNII (FDA Substance ID)

AN164J8Y0X

TRIMETHOPRIM

RxCUI 10829

Orange Book

A091437

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "AN164J8Y0X",
    "rxcui": "10829",
    "inchikey": "IEDVJHCEMCRBQM-UHFFFAOYSA-N",
    "display_name": "TRIMETHOPRIM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "249e938d-f181-47c4-a082-372d65462f33": {
      "match": "brand_token",
      "title": "TRIMETHOPRIM TABLET [LUPIN PHARMACEUTICALS,INC.]",
      "spl_version": "6",
      "published_date": "2024-12-04"
    }
  },
  "productid": "43386-330_6a57562b-424f-40ef-9b86-fa0e66c1c344",
  "productndc": "43386-330",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "091437",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Jun 15, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRIMETHOPRIM",
  "proprietary_name": "Trimethoprim",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091437",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Trimethoprim",
  "start_marketing_date": "20110624",
  "active_numerator_strength": "100"
}

Related drugs

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