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United States Β· US Β· US:68462-294_770b4914-a475-4841-83f8-79261f115eff

Trandolapril and Verapamil Hydrochloride

Orange BookUNIISPLATC C09AA

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeC09AA
Dispensingβ€”
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs Β· 3

  • ndc11
    6846229401
    100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-294-01)
  • ndc11
    6846229410
    1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-294-10)
  • ndc11
    6846229490
    90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-294-90)

Annotations

UNII (FDA Substance ID)
1T0N3G9CRC
TRANDOLAPRIL
RxCUI 38454
Orange Book
A079135
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": "68462-294_770b4914-a475-4841-83f8-79261f115eff",
  "productndc": "68462-294",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "079135",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2MG;180MG",
        "product_no": "001",
        "approval_date": "May 26, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2MG;240MG",
        "product_no": "002",
        "approval_date": "May 26, 2010"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "4MG;240MG",
        "product_no": "003",
        "approval_date": "May 5, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1MG;240MG",
        "product_no": "004",
        "approval_date": "Aug 30, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE",
  "proprietary_name": "Trandolapril and Verapamil Hydrochloride",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA079135",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Trandolapril and Verapamil Hydrochloride",
  "start_marketing_date": "20150225",
  "active_numerator_strength": "1; 240"
}

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