ENTRESTO

Orange BookUNIISPLATC C09DX

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

Identification

ManufacturerNovartis Pharmaceuticals Corporation

CountryUS (United States)

ATC codeC09DX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0078977750
28 TABLET, FILM COATED in 1 BOTTLE (0078-9777-50)

Annotations

UNII (FDA Substance ID)

17ERJ0MKGI

SACUBITRIL

RxCUI 1656328

Orange Book

N207620

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "17ERJ0MKGI",
    "rxcui": "1656328",
    "inchikey": "PYNXFZCZUAOOQC-UTKZUKDTSA-N",
    "display_name": "SACUBITRIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "000dc81d-ab91-450c-8eae-8eb74e72296f": {
      "match": "brand_token",
      "title": "ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED ENTRESTO (SACUBITRIL AND VALSARTAN) PELLET [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "24",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0078-9777_a0cb416b-6ead-4623-949b-ee3d9dd1143a",
  "productndc": "0078-9777",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "207620",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "24MG;26MG",
        "product_no": "001",
        "approval_date": "Jul 7, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "49MG;51MG",
        "product_no": "002",
        "approval_date": "Jul 7, 2015"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "97MG;103MG",
        "product_no": "003",
        "approval_date": "Jul 7, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SACUBITRIL; VALSARTAN",
  "proprietary_name": "ENTRESTO",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA207620",
  "marketing_category": "NDA",
  "nonproprietary_name": "Sacubitril and Valsartan",
  "start_marketing_date": "20150707",
  "active_numerator_strength": "49; 51"
}

Related drugs

Other records sharing ATC code C09DX.

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