Sacubitril and Valsartan

Orange BookUNIISPLATC C09DX

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

Identification

ManufacturerANI Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeC09DX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
7095497620
60 TABLET, FILM COATED in 1 BOTTLE (70954-976-20)
ndc11
7095497630
180 TABLET, FILM COATED in 1 BOTTLE (70954-976-30)
ndc11
7095497650
1000 TABLET, FILM COATED in 1 BOTTLE (70954-976-50)

Annotations

UNII (FDA Substance ID)

17ERJ0MKGI

SACUBITRIL

RxCUI 1656328

Orange Book

A213676

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": "70954-976_fb8d85f8-7a85-422b-82f0-2a4f5d296b07",
  "productndc": "70954-976",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "213676",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "24MG;26MG",
        "product_no": "001",
        "approval_date": "May 28, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "49MG;51MG",
        "product_no": "002",
        "approval_date": "May 28, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "97MG;103MG",
        "product_no": "003",
        "approval_date": "May 28, 2024"
      }
    ],
    "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": "ANDA213676",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sacubitril and Valsartan",
  "start_marketing_date": "20250724",
  "active_numerator_strength": "49; 51"
}

Related drugs

Other records sharing ATC code C09DX.

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