sacubitril and valsartan (72865-311)

Drug Facts

Product Profile

Brand Name sacubitril and valsartan

Generic Name sacubitril and valsartan

Labeler xlcare pharmaceuticals inc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

sacubitril 49 mg/1, valsartan 51 mg/1

Manufacturer

XLCare Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72865-311

Product ID 72865-311_064a7c51-de30-4759-8210-e18438e6a187

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA213728

Listing Expiration 2026-12-31

Marketing Start 2025-09-30

Pharmacologic Class

Established (EPC)

angiotensin 2 receptor blocker [epc]

Mechanism of Action

angiotensin 2 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72865311

Hyphenated Format 72865-311

Supplemental Identifiers

RxCUI

1656340 1656349 1656354

UPC

0372865311189 0372865310601 0372865312186 0372865311608 0372865312605 0372865310182

UNII

80M03YXJ7I 17ERJ0MKGI

NUI

N0000000070 N0000175561

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sacubitril and valsartan (source: ndc)

Generic Name sacubitril and valsartan (source: ndc)

Application Number ANDA213728 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

49 mg/1
51 mg/1

source: ndc

Packaging

180 TABLET in 1 BOTTLE (72865-311-18)
60 TABLET in 1 BOTTLE (72865-311-60)

source: ndc

Packages (2)

72865-311-18 180 TABLET in 1 BOTTLE (72865-311-18) 72865-311-60 60 TABLET in 1 BOTTLE (72865-311-60)

Ingredients (2)

sacubitril (49 mg/1) valsartan (51 mg/1)

Linked Drug Pages (1)

Sacubitril and Valsartan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "064a7c51-de30-4759-8210-e18438e6a187", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0372865311189", "0372865310601", "0372865312186", "0372865311608", "0372865312605", "0372865310182"], "unii": ["80M03YXJ7I", "17ERJ0MKGI"], "rxcui": ["1656340", "1656349", "1656354"], "spl_set_id": ["064a7c51-de30-4759-8210-e18438e6a187"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["XLCare Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET in 1 BOTTLE (72865-311-18)", "package_ndc": "72865-311-18", "marketing_start_date": "20250930"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (72865-311-60)", "package_ndc": "72865-311-60", "marketing_start_date": "20250930"}], "brand_name": "Sacubitril and Valsartan", "product_id": "72865-311_064a7c51-de30-4759-8210-e18438e6a187", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Neprilysin Inhibitor [EPC]", "Neprilysin Inhibitors [MoA]"], "product_ndc": "72865-311", "generic_name": "Sacubitril and Valsartan", "labeler_name": "XLCare Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sacubitril and Valsartan", "active_ingredients": [{"name": "SACUBITRIL", "strength": "49 mg/1"}, {"name": "VALSARTAN", "strength": "51 mg/1"}], "application_number": "ANDA213728", "marketing_category": "ANDA", "marketing_start_date": "20250930", "listing_expiration_date": "20261231"}