ENTRESTO

Orange BookUNIISPLATC C09DX

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeC09DX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7161080737
3120 TABLET, FILM COATED in 1 BOTTLE (71610-807-37)

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": "71610-807_14bfc625-3f5d-cdde-e063-6294a90afeae",
  "productndc": "71610-807",
  "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": "97; 103"
}

Related drugs

Other records sharing ATC code C09DX.

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