Home NDC 71610-806 ENTRESTO
Product NDC 71610-806
11-digit product format 716100806
Labeler code 71610
Product ID 71610-806_14bf8866-17fa-96ec-e063-6294a90ad420
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sacubitril and Valsartan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application NDA207620
Marketing category NDA
Marketing start 2015-07-07
Substance SACUBITRIL; VALSARTAN
Active strength 49; 51 mg/1; mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N207620-001 ENTRESTO SACUBITRIL; VALSARTAN 24MG;26MG TABLET / ORAL AB RLD 2015-07-07 N207620-002 ENTRESTO SACUBITRIL; VALSARTAN 49MG;51MG TABLET / ORAL AB RLD 2015-07-07 N207620-003 ENTRESTO SACUBITRIL; VALSARTAN 97MG;103MG TABLET / ORAL AB RLD, RS 2015-07-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 24 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 126 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N207620-001 ENTRESTO 24MG;26MG TABLET / ORAL AB RLD 2015-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207620-002 ENTRESTO 49MG;51MG TABLET / ORAL AB RLD 2015-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207620-003 ENTRESTO 97MG;103MG TABLET / ORAL AB RLD, RS 2015-07-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207620-001 ENTRESTO 24MG;26MG TABLET / ORAL AB RLD 2015-07-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207620-002 ENTRESTO 49MG;51MG TABLET / ORAL AB RLD 2015-07-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207620-003 ENTRESTO 97MG;103MG TABLET / ORAL AB RLD, RS 2015-07-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207620-001 ENTRESTO 24MG;26MG TABLET / ORAL AB RLD 2015-07-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207620-002 ENTRESTO 49MG;51MG TABLET / ORAL AB RLD 2015-07-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207620-003 ENTRESTO 97MG;103MG TABLET / ORAL AB RLD, RS 2015-07-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207620-001 ENTRESTO 24MG;26MG TABLET / ORAL AB RLD 2015-07-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207620-002 ENTRESTO 49MG;51MG TABLET / ORAL AB RLD 2015-07-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207620-003 ENTRESTO 97MG;103MG TABLET / ORAL AB RLD, RS 2015-07-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207620-001 ENTRESTO 24MG;26MG TABLET / ORAL AB RLD 2015-07-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207620-002 ENTRESTO 49MG;51MG TABLET / ORAL AB RLD 2015-07-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207620-003 ENTRESTO 97MG;103MG TABLET / ORAL AB RLD, RS 2015-07-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207620-001 ENTRESTO 24MG;26MG TABLET / ORAL AB RLD 2015-07-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207620-002 ENTRESTO 49MG;51MG TABLET / ORAL AB RLD 2015-07-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207620-003 ENTRESTO 97MG;103MG TABLET / ORAL AB RLD, RS 2015-07-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207620-001 ENTRESTO 24MG;26MG TABLET / ORAL AB RLD 2015-07-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207620-002 ENTRESTO 49MG;51MG TABLET / ORAL AB RLD 2015-07-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207620-003 ENTRESTO 97MG;103MG TABLET / ORAL AB RLD, RS 2015-07-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207620-001 ENTRESTO 24MG;26MG TABLET / ORAL AB RLD 2015-07-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207620-002 ENTRESTO 49MG;51MG TABLET / ORAL AB RLD 2015-07-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207620-003 ENTRESTO 97MG;103MG TABLET / ORAL AB RLD, RS 2015-07-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207620-001 ENTRESTO 24MG;26MG TABLET / ORAL AB RLD 2015-07-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207620-002 ENTRESTO 49MG;51MG TABLET / ORAL AB RLD 2015-07-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207620-003 ENTRESTO 97MG;103MG TABLET / ORAL AB RLD, RS 2015-07-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207620-001 ENTRESTO 24MG;26MG TABLET / ORAL AB RLD 2015-07-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207620-002 ENTRESTO 49MG;51MG TABLET / ORAL AB RLD 2015-07-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207620-003 ENTRESTO 97MG;103MG TABLET / ORAL AB RLD, RS 2015-07-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207620-001 ENTRESTO 24MG;26MG TABLET / ORAL AB RLD 2015-07-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207620-002 ENTRESTO 49MG;51MG TABLET / ORAL AB RLD 2015-07-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207620-003 ENTRESTO 97MG;103MG TABLET / ORAL AB RLD, RS 2015-07-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207620-001 ENTRESTO 24MG;26MG TABLET / ORAL AB RLD 2015-07-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207620-002 ENTRESTO 49MG;51MG TABLET / ORAL AB RLD 2015-07-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207620-003 ENTRESTO 97MG;103MG TABLET / ORAL AB RLD, RS 2015-07-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207620-001 ENTRESTO 24MG;26MG TABLET / ORAL AB RLD 2015-07-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207620-002 ENTRESTO 49MG;51MG TABLET / ORAL AB RLD 2015-07-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207620-003 ENTRESTO 97MG;103MG TABLET / ORAL AB RLD, RS 2015-07-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207620-001 ENTRESTO 24MG;26MG TABLET / ORAL AB RLD 2015-07-07 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 45 observed states.
Observed Orange Book patent history# Patent history page 1 of 40 · 1,581 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N207620-001 9388134 2026-11-08 U-1723 2016-09-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207620-001 9388134*PED 2027-05-08 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207620-001 8877938 2027-05-27 Drug substance, Drug product 2015-08-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207620-001 8877938*PED 2027-11-27 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207620-001 11135192 2033-08-22 U-3084 2021-10-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207620-001 9517226 2033-08-22 U-3084 2021-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207620-001 9937143 2033-08-22 U-3084 2021-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207620-001 11058667 2036-05-09 U-3170 2021-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207620-002 9388134 2026-11-08 U-1723 2016-09-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207620-002 9388134*PED 2027-05-08 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207620-002 8877938 2027-05-27 Drug substance, Drug product 2015-08-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207620-002 8877938*PED 2027-11-27 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207620-002 11135192 2033-08-22 U-3084 2021-10-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207620-002 9517226 2033-08-22 U-3084 2021-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207620-002 9937143 2033-08-22 U-3084 2021-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207620-002 11058667 2036-05-09 U-3170 2021-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207620-003 9388134 2026-11-08 U-1723 2016-09-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207620-003 9388134*PED 2027-05-08 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207620-003 8877938 2027-05-27 Drug substance, Drug product 2015-08-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207620-003 8877938*PED 2027-11-27 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207620-003 11135192 2033-08-22 U-3084 2021-10-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207620-003 9517226 2033-08-22 U-3084 2021-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207620-003 9937143 2033-08-22 U-3084 2021-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207620-003 11058667 2036-05-09 U-3170 2021-07-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207620-001 9388134 2026-11-08 U-1723 2016-09-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207620-001 9388134*PED 2027-05-08 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207620-001 8877938 2027-05-27 Drug substance, Drug product 2015-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207620-001 8877938*PED 2027-11-27 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207620-001 11135192 2033-08-22 U-3084 2021-10-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207620-001 9517226 2033-08-22 U-3084 2021-03-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207620-001 9937143 2033-08-22 U-3084 2021-03-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207620-001 11058667 2036-05-09 U-3170 2021-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207620-002 9388134 2026-11-08 U-1723 2016-09-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207620-002 9388134*PED 2027-05-08 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207620-002 8877938 2027-05-27 Drug substance, Drug product 2015-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207620-002 8877938*PED 2027-11-27 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207620-002 11135192 2033-08-22 U-3084 2021-10-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207620-002 9517226 2033-08-22 U-3084 2021-03-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207620-002 9937143 2033-08-22 U-3084 2021-03-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207620-002 11058667 2036-05-09 U-3170 2021-07-13 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 6 · 237 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ENTRESTO
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SACUBITRIL 49 mg/1 VALSARTAN 51 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 17ERJ0MKGI Internal UNII lookup 80M03YXJ7I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1656349 Internal RxNorm lookup 1656351 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71610-806-32 ENTRESTO 780 in 1 BOTTLE TABLET, FILM COATED 780 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-806 ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ] 1 Current NDC, 1 package rows 20240330_14bf8041-0b7f-9acb-e063-6294a90a8256.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ENTRESTO SACUBITRIL AND VALSARTAN Novartis Pharmaceuticals Corporation 000dc81d-ab91-450c-8eae-8eb74e72296f 2026-07-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 207620 application number: NDA207620 ENTRESTO SACUBITRIL AND VALSARTAN Aphena Pharma Solutions - Tennessee, LLC 152335bf-12c4-28e6-e063-6294a90ac20f 2025-06-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 207620 application number: NDA207620 ENTRESTO SACUBITRIL AND VALSARTAN Aphena Pharma Solutions - Tennessee, LLC 14bf8041-0b7f-9acb-e063-6294a90a8256 2024-03-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 207620 application number: NDA207620 ndc (product): 71610-806 ENTRESTO SACUBITRIL AND VALSARTAN Aphena Pharma Solutions - Tennessee, LLC 14bfc60a-9ddf-cac7-e063-6294a90a597b 2024-03-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 207620 application number: NDA207620
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71610-806-32 71610080632 780 TABLET, FILM COATED in 1 BOTTLE (71610-806-32) 2024-03-22 No No Current