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United States· US:13668-636_d75a5a57-6ab2-4aa3-abc5-de648ac84e65

sacubitril and valsartan

A angiotensin ii receptor blockers (arbs), other combinations product containing sacubitril and valsartan, registered in United States by Torrent Pharmaceuticals Limited.

ATC C09DXOrange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedsacubitril and valsartanATCC09DXREGISTER NO.US:13668-636_d75a5a57…PACKS LISTED4CHECKEDJune 3, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
sacubitril and valsartan
Manufacturer
Torrent Pharmaceuticals Limited
Country
United States (US)
ATC code
C09DX
ATC class
Angiotensin II receptor blockers (ARBs), other combinations
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 4

  • ndc11
    1366863605
    500 TABLET in 1 BOTTLE (13668-636-05)
  • ndc11
    1366863633
    180 TABLET in 1 BOTTLE (13668-636-33)
  • ndc11
    1366863660
    60 TABLET in 1 BOTTLE (13668-636-60)
  • ndc11
    1366863674
    100 BLISTER PACK in 1 CARTON (13668-636-74) / 10 TABLET in 1 BLISTER PACK (13668-636-71)

Regulatory notes

UNII (FDA substance ID)
17ERJ0MKGI
SACUBITRIL
RxCUI 1656328
Orange Book
A213604
ABABAB
DailyMed SPL labels
1 version tracked

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/4a805263-88f7-4917-b8c7-37d980385191
GET /v1/drugs/4a805263-88f7-4917-b8c7-37d980385191?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "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": "13668-636_d75a5a57-6ab2-4aa3-abc5-de648ac84e65",
  "productndc": "13668-636",
  "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": "97; 103"
}

See everything about sacubitril and valsartan.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.