Sacubitril and Valsartan

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 · 2

ndc11
7161093932
780 TABLET, FILM COATED in 1 BOTTLE (71610-939-32)
ndc11
7161093989
720 TABLET, FILM COATED in 1 BOTTLE (71610-939-89)

Annotations

UNII (FDA Substance ID)

17ERJ0MKGI

SACUBITRIL

RxCUI 1656328

Orange Book

A213748

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": {
    "a1fa7066-8ab4-47e3-a701-6c5170700d11": {
      "match": "brand_token",
      "title": "SACUBITRIL AND VALSARTAN TABLET, FILM COATED [ANI PHARMACEUTICALS, INC.]",
      "spl_version": "2",
      "published_date": "2026-05-28"
    }
  },
  "productid": "71610-939_3dd750a5-346a-e671-e063-6394a90a9cf4",
  "productndc": "71610-939",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "213748",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "24MG;26MG",
        "product_no": "001",
        "approval_date": "Jul 16, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "49MG;51MG",
        "product_no": "002",
        "approval_date": "Jul 16, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "97MG;103MG",
        "product_no": "003",
        "approval_date": "Jul 16, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SACUBITRIL; VALSARTAN",
  "proprietary_name": "Sacubitril and Valsartan",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA213748",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sacubitril and Valsartan",
  "start_marketing_date": "20250121",
  "active_numerator_strength": "49; 51"
}

Related drugs

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