Drugplain

Sacubitril and Valsartan 49 mg/1

Sacubitril and Valsartan · TABLET · XLCare Pharmaceuticals Inc

No Recall History
Plain English

Sacubitril and valsartan is a prescription tablet that combines two medicines to help treat heart failure by relaxing blood vessels and reducing the workload on the heart. This medication belongs to a drug class that blocks angiotensin II, a hormone that narrows blood vessels and raises blood pressure.

Key Facts

Brand Name
Sacubitril and Valsartan
Generic Name
Sacubitril and Valsartan
NDC Code (Product)
72865-311
Manufacturer
XLCare Pharmaceuticals Inc
Strength
49 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA213728
Drug Class
Angiotensin 2 Receptor Blocker [EPC]
Marketing Start
09/30/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dehydration2 reports
dyspnoea2 reports
hypotension2 reports
urinary tract infection2 reports
abdominal distension1 reports
acute kidney injury1 reports
atrial fibrillation1 reports
cardiac failure1 reports
chest discomfort1 reports
contusion1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and sacubitril and valsartan tablets are indicated: • to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. ( 1.1 ) • for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan reduces NT-proBNP and is expected to improve cardiovascular outcomes. ( 1.2 ) 1.1 Adult Heart Failure Sacubitril and valsartan tablets are indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. LVEF is a variable measure, so use clinical judgment in deciding whom to treat [ see Clinical Studies ( 14.1 )] . 1.2 Pediatric Heart Failure Sacubitril and valsartan tablets are indi…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • The recommended starting dosage for adults is 49 mg/51 mg orally twice daily. The target maintenance dose is 97 mg/103 mg orally twice daily. ( 2.2 ) • Adjust adult doses every 2 to 4 weeks to the target maintenance dose, as tolerated by the patient. ( 2.2 ) • For pediatric patients, see the Full Prescribing Information for recommended dosage, titrations, preparation and administration instructions. ( 2.3 , 2.4 ) • Reduce starting dose to half the usually recommended starting dosage for: o patients not currently taking an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) or previously taking a low dose of these agents. ( 2.6 ) o patients with severe renal impairment. ( 2.7 ) o patients with moderate hepatic impairment. ( 2.8 ) 2.1 General Considerations Sacubitril and valsartan tablets are contraindicated with concomitant use of an angiotensin-converting enzyme (ACE) inhibitor. If switching from an ACE inhibitor to sacubitril and valsartan tablets allow a washout period of 36 hours between administration of the two drugs [see Contraindications ( 4 ) and Drug Interactions ( 7.1 )]. 2.2 Adult Heart Failure The recomme…

Contraindications

4 CONTRAINDICATIONS Sacubitril and valsartan tablets are contraindicated: • in patients with hypersensitivity to any component • in patients with a history of angioedema related to previous ACE inhibitor or ARB therapy [see Warnings and Precautions ( 5.2 )] • with concomitant use of ACE inhibitors. Do not administer within 36 hours of switching from or to an ACE inhibitor [see Drug Interactions ( 7.1 )] • with concomitant use of aliskiren in patients with diabetes [see Drug Interactions ( 7.1 )] Hypersensitivity to any component. ( 4 ) History of angioedema related to previous ACEi or ARB therapy. ( 4 ) Concomitant use with ACE inhibitors. ( 4 , 7.1 ) Concomitant use with aliskiren in patients with diabetes. ( 4 , 7.1 )

Drug Interactions

7 DRUG INTERACTIONS • Avoid concomitant use with aliskiren in patients with estimated glomerular filtration rate (eGFR) less than 60. ( 7.1 ) • Potassium-sparing diuretics: May lead to increased serum potassium. ( 7.2 ) • Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): May lead to increased risk of renal impairment. ( 7.3 ) • Lithium: Increased risk of lithium toxicity. ( 7.4 ) 7.1 Dual Blockade of the Renin-Angiotensin-Aldosterone System Concomitant use of sacubitril and valsartan tablets with an ACE inhibitor is contraindicated because of the increased risk of angioedema [see Contraindications ( 4 )] . Avoid use of sacubitril and valsartan tablets with an ARB, because sacubitril and valsartan tablets contains the angiotensin II receptor blocker valsartan. The concomitant use of sacubitril and valsartan tablets with aliskiren is contraindicated in patients with diabetes [see Contraindications ( 4 )] . Avoid use with aliskiren in patients with renal impairment (eGFR less than 60 mL/min/1.73 m²). 7.2 Potassium-Sparing Diuretics As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), p…

Adverse Reactions

6 ADVERSE REACTIONS Clinically significant adverse reactions that appear in other sections of the labeling include: • Angioedema [see Warnings and Precautions ( 5.2 )] • Hypotension [see Warnings and Precautions ( 5.3 )] • Impaired Renal Function [see Warnings and Precautions ( 5.4 )] • Hyperkalemia [see Warnings and Precautions ( 5.5 )] Adverse reactions occurring greater than or equal to 5% are hypotension, hyperkalemia, cough, dizziness, and renal failure. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact XLCare Pharmaceuticals, Inc. at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 6,622 heart failure patients were treated with sacubitril and valsartan in the PARADIGM-HF (vs. enalapril) and PARAGON-HF (vs. valsartan) clinical trials. Of these, 5,085 were exposed for at least 1 year. Adult Heart Failure In PARADIGM-HF, patients were required to complete se…

Frequently Asked Questions

What is Sacubitril and Valsartan used for?

Sacubitril and valsartan is a prescription tablet that combines two medicines to help treat heart failure by relaxing blood vessels and reducing the workload on the heart. This medication belongs to a drug class that blocks angiotensin II, a hormone that narrows blood vessels and raises blood pressure.

Is Sacubitril and Valsartan a controlled substance?

Sacubitril and Valsartan is not classified as a controlled substance by the DEA.

What is the generic name for Sacubitril and Valsartan?

The generic name for Sacubitril and Valsartan is Sacubitril and Valsartan. There are 8 other brand versions of Sacubitril and Valsartan.

What is the NDC code for Sacubitril and Valsartan 49 mg/1?

The NDC (National Drug Code) for Sacubitril and Valsartan 49 mg/1 is 72865-311, listed by XLCare Pharmaceuticals Inc.

Product NDC

72865-311

Package NDC

72865-311-10

Other Sacubitril Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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