Home NDC 0078-0777 ENTRESTO
Product NDC 0078-0777
11-digit product format 000780777
Labeler code 0078
Product ID 0078-0777_a0cb416b-6ead-4623-949b-ee3d9dd1143a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sacubitril and Valsartan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 123 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 2026-02-19 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…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207620-002 ENTRESTO 49MG;51MG TABLET / ORAL AB RLD 2015-07-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207620-003 ENTRESTO 97MG;103MG TABLET / ORAL AB RLD, RS 2015-07-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207620-001 ENTRESTO 24MG;26MG TABLET / ORAL RLD 2015-07-07 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book patent history# Patent history page 1 of 39 · 1,557 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 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…2026-02-19 14:30 UTC 2026-02 N207620-003 9388134 2026-11-08 U-1723 2016-09-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207620-003 9388134*PED 2027-05-08 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207620-003 8877938 2027-05-27 Drug substance, Drug product 2015-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207620-003 8877938*PED 2027-11-27 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207620-003 11135192 2033-08-22 U-3084 2021-10-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207620-003 9517226 2033-08-22 U-3084 2021-03-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207620-003 9937143 2033-08-22 U-3084 2021-03-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207620-003 11058667 2036-05-09 U-3170 2021-07-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207620-001 8101659 2025-01-15 Drug product 2015-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207620-001 8101659*PED 2025-07-15 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207620-001 9388134 2026-11-08 U-1723 2016-09-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207620-001 9388134*PED 2027-05-08 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207620-001 8877938 2027-05-27 Drug substance, Drug product 2015-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207620-001 8877938*PED 2027-11-27 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207620-001 11135192 2033-08-22 U-3084 2021-10-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207620-001 9517226 2033-08-22 U-3084 2021-03-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207620-001 9937143 2033-08-22 U-3084 2021-03-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207620-001 11058667 2036-05-09 U-3170 2021-07-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207620-002 8101659 2025-01-15 Drug product 2015-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207620-002 8101659*PED 2025-07-15 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207620-002 9388134 2026-11-08 U-1723 2016-09-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207620-002 9388134*PED 2027-05-08 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207620-002 8877938 2027-05-27 Drug substance, Drug product 2015-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207620-002 8877938*PED 2027-11-27 Pediatric extension 31067a03dcf5…
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 2027-12-31 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 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1656340 Internal RxNorm lookup 1656346 Internal RxNorm lookup 1656349 Internal RxNorm lookup 1656351 Internal RxNorm lookup 1656354 Internal RxNorm lookup 1656356 Internal RxNorm lookup 2679793 Internal RxNorm lookup 2679797 Internal RxNorm lookup 2679800 Internal RxNorm lookup 2679802 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 0078-0777-20 2024-02-02 These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015 0078-0777-20 2024-02-02 These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015 0078-0777-20 2024-02-02 These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015 0078-0777-35 2024-02-02 These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015 0078-0777-35 2024-02-02 These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015 0078-0777-35 2024-02-02 These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015 0078-0777-67 2024-02-02 These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015 0078-0777-67 2024-02-02 These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015 0078-0777-67 2024-02-02 These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015 0078-0777-20 2024-01-30 These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015 0078-0777-20 2024-01-30 These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015 0078-0777-20 2024-01-30 These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015 0078-0777-35 2024-01-30 These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015 0078-0777-35 2024-01-30 These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015 0078-0777-35 2024-01-30 These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015 0078-0777-67 2024-01-30 These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015 0078-0777-67 2024-01-30 These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015 0078-0777-67 2024-01-30 These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use ENTRESTO ® SPRINKLE (sacubitril and valsartan) oral pellets Initial U.S. Approval: 2015
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0078-0777-20 ENTRESTO 60 in 1 BOTTLE TABLET, FILM COATED 60 24 0078-0777-35 ENTRESTO 100 in 1 BOX, UNIT-DOSE TABLET, FILM COATED 100 24 0078-0777-61 ENTRESTO 1 in 1 BLISTER PACK TABLET, FILM COATED 1 24 0078-0777-67 ENTRESTO 180 in 1 BOTTLE TABLET, FILM COATED 180 24
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SACUBITRIL ACTIVE INGREDIENT 17ERJ0MKGI ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 2 VALSARTAN ACTIVE INGREDIENT 80M03YXJ7I ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 2 SACUBITRIL ACTIVE MOIETY 17ERJ0MKGI ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 2 VALSARTAN ACTIVE MOIETY 80M03YXJ7I ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 2 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 2 POLYETHYLENE GLYCOL 4000 INACTIVE INGREDIENT 4R4HFI6D95 ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0777 ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED ENTRESTO (SACUBITRIL AND VALSARTAN) PELLET [NOVARTIS PHARMACEUTICALS CORPORATION] 22 Current NDC, Legacy NDC, 4 package rows 20250122_000dc81d-ab91-450c-8eae-8eb74e72296f.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 ndc (product): 0078-0777 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 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 Marketing end Sample Exclude flag Status 0078-0777-20 00078077720 60 TABLET, FILM COATED in 1 BOTTLE (0078-0777-20) 2015-07-07 0000-00-00 No No Current 0078-0777-35 00078077735 100 in 1 BOX, UNIT-DOSE Historical 0078-0777-61 00078077761 1 in 1 BLISTER PACK Historical 0078-0777-67 00078077767 180 TABLET, FILM COATED in 1 BOTTLE (0078-0777-67) 2015-07-07 0000-00-00 No No Current