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United States · US · US:42806-054_71e96bed-1a18-49d6-e053-2995a90a3014

Trandolapril

Orange BookUNIISPLATC C09AA10

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerEpic Pharma, LLC
CountryUS (United States)
ATC codeC09AA10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4280605401
    100 TABLET in 1 BOTTLE (42806-054-01)
  • ndc11
    4280605410
    1000 TABLET in 1 BOTTLE (42806-054-10)

Annotations

UNII (FDA Substance ID)
1T0N3G9CRC
TRANDOLAPRIL
RxCUI 38454
Orange Book
A078508
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "1T0N3G9CRC",
    "rxcui": "38454",
    "inchikey": "VXFJYXUZANRPDJ-WTNASJBWSA-N",
    "display_name": "TRANDOLAPRIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "39bad727-af4c-4d20-933b-7f287e88099a": {
      "match": "brand_token",
      "title": "TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]",
      "spl_version": "13",
      "published_date": "2026-01-30"
    }
  },
  "productid": "42806-054_71e96bed-1a18-49d6-e053-2995a90a3014",
  "productndc": "42806-054",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078508",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Jun 18, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "002",
        "approval_date": "Jun 18, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "003",
        "approval_date": "Jun 18, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRANDOLAPRIL",
  "proprietary_name": "Trandolapril",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078508",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Trandolapril Tablets",
  "start_marketing_date": "20150331",
  "active_numerator_strength": "4"
}

Related drugs

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