OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

ENTRESTO

Sacubitril and Valsartan · Pellet

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
ENTRESTO
Generic name
Sacubitril and Valsartan
Dosage form
Pellet
Route
Oral
Marketing category
NDA · NDA
Labeler
Novartis Pharmaceuticals Corporation
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Sacubitril 15 mg/1 1656340 View
Sacubitril 6 mg/1 1656340 View
Valsartan 16 mg/1 1656340 View
Valsartan 6 mg/1 1656340 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Pellet
Route of administration
Oral
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Angiotensin 2 Receptor Antagonists [MoA] MoA All 63 members
Angiotensin 2 Receptor Blocker [EPC] EPC All 67 members
Neprilysin Inhibitor [EPC] EPC 4 members — no class page
Neprilysin Inhibitors [MoA] MoA 4 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
218591
Application type
NDA · New Drug Application
Approval date
April 12, 2024
Sponsor
NOVARTIS
Products on application
2
Submissions recorded
1
Products approved under application 218591.
Product Trade name Form Strength Ingredient Status TE Flags
218591-001 ENTRESTO SPRINKLE CAPSULE, PELLETS SACUBITRIL; VALSARTAN Prescription — RLD
218591-002 ENTRESTO SPRINKLE CAPSULE, PELLETS SACUBITRIL; VALSARTAN Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
9388134 November 8, 2026 001 No U-1723 May 8, 2024
9388134 November 8, 2026 002 No U-1723 May 8, 2024
8877938 May 27, 2027 001 Yes May 8, 2024
8877938 May 27, 2027 002 Yes May 8, 2024
10722471 February 2, 2037 001 No U-3896 May 8, 2024
10722471 February 2, 2037 002 No U-3896 May 8, 2024

Approval history

Source: Drugs@FDA
Most recent submissions on application 218591.
Type No. Action Status Date Review
Original application 1 Type 3 - New Dosage Form Approved April 12, 2024 Standard

Review documents

  • 0 · Original application · September 23, 2024
  • 0 · Original application · July 1, 2024
  • 0 · Original application · April 15, 2024

Adverse event reports

Source: openFDA FAERS
244,889
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: VALSARTAN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0078-1231-20 0078-1231 Novartis Pharmaceuticals Corporation 60 PELLET in 1 BOTTLE (0078-1231-20) April 12, 2024
0078-1238-20 0078-1238 Novartis Pharmaceuticals Corporation 60 PELLET in 1 BOTTLE (0078-1238-20) April 12, 2024
0078-1231 0078-1231 Novartis Pharmaceuticals Corporation — April 12, 2024
0078-1238 0078-1238 Novartis Pharmaceuticals Corporation — April 12, 2024

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.