Sacubitril and Valsartan

Orange BookUNIISPLATC C09DX

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

Identification

ManufacturerBiocon Pharma Inc.

CountryUS (United States)

ATC codeC09DX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7037703311
30 TABLET, FILM COATED in 1 BOTTLE (70377-033-11)
ndc11
7037703312
60 TABLET, FILM COATED in 1 BOTTLE (70377-033-12)
ndc11
7037703313
180 TABLET, FILM COATED in 1 BOTTLE (70377-033-13)
ndc11
7037703314
500 TABLET, FILM COATED in 1 BOTTLE (70377-033-14)

Annotations

UNII (FDA Substance ID)

17ERJ0MKGI

SACUBITRIL

RxCUI 1656328

Orange Book

A213680

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": "70377-033_600f67e2-7ccf-65d9-012c-e7ba9b8a089f",
  "productndc": "70377-033",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "213680",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "24MG;26MG",
        "product_no": "001",
        "approval_date": "Aug 30, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "49MG;51MG",
        "product_no": "002",
        "approval_date": "Aug 30, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "97MG;103MG",
        "product_no": "003",
        "approval_date": "Aug 30, 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": "ANDA213680",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sacubitril and Valsartan",
  "start_marketing_date": "20250717",
  "active_numerator_strength": "97; 103"
}

Related drugs

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