Zestril

Orange BookUNIISPLATC C09AA03

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

Identification

ManufacturerUpsher-Smith Laboratories, LLC

CountryUS (United States)

ATC codeC09AA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2497923807
90 TABLET in 1 BOTTLE (24979-238-07)

Annotations

UNII (FDA Substance ID)

E7199S1YWR

LISINOPRIL

RxCUI 29046

Orange Book

N019777

ABABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "E7199S1YWR",
    "rxcui": "29046",
    "inchikey": "CZRQXSDBMCMPNJ-ZUIPZQNBSA-N",
    "display_name": "LISINOPRIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8": {
      "match": "brand_token",
      "title": "ZESTRIL (LISINOPRIL) TABLET [UPSHER-SMITH LABORATORIES, LLC]",
      "spl_version": "2",
      "published_date": "2025-05-05"
    }
  },
  "productid": "24979-238_7875efff-59e3-4f68-84c5-e3c9c16d6a3c",
  "productndc": "24979-238",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "019777",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "May 19, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "May 19, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "May 19, 1988"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "004",
        "approval_date": "May 19, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "005",
        "approval_date": "Apr 29, 1993"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "006",
        "approval_date": "Jan 20, 1999"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LISINOPRIL",
  "proprietary_name": "Zestril",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA019777",
  "marketing_category": "NDA",
  "nonproprietary_name": "Lisinopril",
  "start_marketing_date": "20240425",
  "active_numerator_strength": "2.5"
}

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