sacubitril and valsartan

Orange BookUNIISPLATC C09DX

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

Identification

ManufacturerTorrent Pharmaceuticals Limited

CountryUS (United States)

ATC codeC09DX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
1366863505
500 TABLET in 1 BOTTLE (13668-635-05)
ndc11
1366863533
180 TABLET in 1 BOTTLE (13668-635-33)
ndc11
1366863560
60 TABLET in 1 BOTTLE (13668-635-60)
ndc11
1366863574
100 BLISTER PACK in 1 CARTON (13668-635-74) / 10 TABLET in 1 BLISTER PACK (13668-635-71)

Annotations

UNII (FDA Substance ID)

17ERJ0MKGI

SACUBITRIL

RxCUI 1656328

Orange Book

A213604

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": "13668-635_d75a5a57-6ab2-4aa3-abc5-de648ac84e65",
  "productndc": "13668-635",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213604",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "24MG;26MG",
        "product_no": "001",
        "approval_date": "Aug 22, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "49MG;51MG",
        "product_no": "002",
        "approval_date": "Aug 22, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "97MG;103MG",
        "product_no": "003",
        "approval_date": "Aug 22, 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": "ANDA213604",
  "marketing_category": "ANDA",
  "nonproprietary_name": "sacubitril and valsartan",
  "start_marketing_date": "20250716",
  "active_numerator_strength": "49; 51"
}

Related drugs

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