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United States · US · US:63629-8003_6393820e-daaa-41b2-b2cb-5fe6c433a854

Trandolapril

Orange BookUNIISPLATC C09AA10

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC09AA10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6362980031
    30 TABLET in 1 BOTTLE (63629-8003-1)
  • ndc11
    6362980032
    90 TABLET in 1 BOTTLE (63629-8003-2)

Annotations

UNII (FDA Substance ID)
1T0N3G9CRC
TRANDOLAPRIL
RxCUI 38454
Orange Book
A077522
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": "63629-8003_6393820e-daaa-41b2-b2cb-5fe6c433a854",
  "productndc": "63629-8003",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077522",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Jun 12, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Jun 12, 2007"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "003",
        "approval_date": "Jun 12, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRANDOLAPRIL",
  "proprietary_name": "Trandolapril",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077522",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Trandolapril",
  "start_marketing_date": "20070611",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code C09AA10.

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