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United States · US · US:68462-295_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
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6846229501
    100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-295-01)
  • ndc11
    6846229510
    1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-295-10)
  • ndc11
    6846229590
    90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-295-90)

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": "68462-295_770b4914-a475-4841-83f8-79261f115eff",
  "productndc": "68462-295",
  "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": "2; 180"
}

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