Home NDC 0078-1231 ENTRESTO
Product NDC 0078-1231
11-digit product format 000781231
Labeler code 0078
Product ID 0078-1231_a0cb416b-6ead-4623-949b-ee3d9dd1143a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sacubitril and Valsartan
Dosage form PELLET
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
Application NDA218591
Marketing category NDA
Marketing start 2024-04-12
Substance SACUBITRIL; VALSARTAN
Active strength 6; 6 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218591-001 ENTRESTO SPRINKLE SACUBITRIL; VALSARTAN 6MG;6MG CAPSULE, PELLETS / ORAL RLD 2024-04-12 N218591-002 ENTRESTO SPRINKLE SACUBITRIL; VALSARTAN 15MG;16MG CAPSULE, PELLETS / ORAL RLD, RS 2024-04-12
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218591-001 9388134 2026-11-08 U-1723 2024-05-08 N218591-001 8877938 2027-05-27 Drug substance, Drug product 2024-05-08 N218591-001 10722471 2037-02-02 U-3896 Drug product 2024-05-08 N218591-002 9388134 2026-11-08 U-1723 2024-05-08 N218591-002 8877938 2027-05-27 Drug substance, Drug product 2024-05-08 N218591-002 10722471 2037-02-02 U-3896 Drug product 2024-05-08
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.
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 N218591-001 ENTRESTO SPRINKLE 6MG;6MG CAPSULE, PELLETS / ORAL RLD 2024-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218591-002 ENTRESTO SPRINKLE 15MG;16MG CAPSULE, PELLETS / ORAL RLD, RS 2024-04-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218591-001 ENTRESTO SPRINKLE 6MG;6MG CAPSULE, PELLETS / ORAL RLD 2024-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218591-002 ENTRESTO SPRINKLE 15MG;16MG CAPSULE, PELLETS / ORAL RLD, RS 2024-04-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218591-001 ENTRESTO SPRINKLE 6MG;6MG CAPSULE, PELLETS / ORAL RLD 2024-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218591-002 ENTRESTO SPRINKLE 15MG;16MG CAPSULE, PELLETS / ORAL RLD, RS 2024-04-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218591-001 ENTRESTO SPRINKLE 6MG;6MG CAPSULE, PELLETS / ORAL RLD 2024-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218591-002 ENTRESTO SPRINKLE 15MG;16MG CAPSULE, PELLETS / ORAL RLD, RS 2024-04-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218591-001 ENTRESTO SPRINKLE 6MG;6MG CAPSULE, PELLETS / ORAL RLD 2024-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218591-002 ENTRESTO SPRINKLE 15MG;16MG CAPSULE, PELLETS / ORAL RLD, RS 2024-04-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218591-001 ENTRESTO SPRINKLE 6MG;6MG CAPSULE, PELLETS / ORAL RLD 2024-04-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218591-002 ENTRESTO SPRINKLE 15MG;16MG CAPSULE, PELLETS / ORAL RLD, RS 2024-04-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218591-001 ENTRESTO SPRINKLE 6MG;6MG CAPSULE, PELLETS / ORAL RLD 2024-04-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218591-002 ENTRESTO SPRINKLE 15MG;16MG CAPSULE, PELLETS / ORAL RLD, RS 2024-04-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218591-001 ENTRESTO SPRINKLE 6MG;6MG CAPSULE, PELLETS / ORAL RLD 2024-04-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218591-002 ENTRESTO SPRINKLE 15MG;16MG CAPSULE, PELLETS / ORAL RLD, RS 2024-04-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218591-001 ENTRESTO SPRINKLE 6MG;6MG CAPSULE, PELLETS / ORAL RLD 2024-04-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218591-002 ENTRESTO SPRINKLE 15MG;16MG CAPSULE, PELLETS / ORAL RLD, RS 2024-04-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218591-001 ENTRESTO SPRINKLE 6MG;6MG CAPSULE, PELLETS / ORAL RLD 2024-04-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218591-002 ENTRESTO SPRINKLE 15MG;16MG CAPSULE, PELLETS / ORAL RLD, RS 2024-04-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N218591-001 ENTRESTO SPRINKLE 6MG;6MG CAPSULE, PELLETS / ORAL RLD 2024-04-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N218591-002 ENTRESTO SPRINKLE 15MG;16MG CAPSULE, PELLETS / ORAL RLD, RS 2024-04-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218591-001 ENTRESTO SPRINKLE 6MG;6MG CAPSULE, PELLETS / ORAL RLD 2024-04-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218591-002 ENTRESTO SPRINKLE 15MG;16MG CAPSULE, PELLETS / ORAL RLD, RS 2024-04-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218591-001 ENTRESTO SPRINKLE 6MG;6MG CAPSULE, PELLETS / ORAL RLD 2024-04-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218591-002 ENTRESTO SPRINKLE 15MG;16MG CAPSULE, PELLETS / ORAL RLD, RS 2024-04-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N218591-001 ENTRESTO SPRINKLE 6MG;6MG CAPSULE, PELLETS / ORAL RLD 2024-04-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N218591-002 ENTRESTO SPRINKLE 15MG;16MG CAPSULE, PELLETS / ORAL RLD, RS 2024-04-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N218591-001 ENTRESTO SPRINKLE 6MG;6MG CAPSULE, PELLETS / ORAL RLD 2024-04-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N218591-002 ENTRESTO SPRINKLE 15MG;16MG CAPSULE, PELLETS / ORAL RLD, RS 2024-04-12 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218591-001 ENTRESTO SPRINKLE 6MG;6MG CAPSULE, PELLETS / ORAL RLD 2024-04-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218591-002 ENTRESTO SPRINKLE 15MG;16MG CAPSULE, PELLETS / ORAL RLD, RS 2024-04-12 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 122 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 N218591-001 9388134 2026-11-08 U-1723 2024-05-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218591-001 8877938 2027-05-27 Drug substance, Drug product 2024-05-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218591-001 10722471 2037-02-02 U-3896 Drug product 2024-05-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218591-002 9388134 2026-11-08 U-1723 2024-05-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218591-002 8877938 2027-05-27 Drug substance, Drug product 2024-05-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218591-002 10722471 2037-02-02 U-3896 Drug product 2024-05-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218591-001 9388134 2026-11-08 U-1723 2024-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218591-001 8877938 2027-05-27 Drug substance, Drug product 2024-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218591-001 10722471 2037-02-02 U-3896 Drug product 2024-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218591-002 9388134 2026-11-08 U-1723 2024-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218591-002 8877938 2027-05-27 Drug substance, Drug product 2024-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218591-002 10722471 2037-02-02 U-3896 Drug product 2024-05-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218591-001 8101659 2025-01-15 Drug product 2024-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218591-001 9388134 2026-11-08 U-1723 2024-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218591-001 8877938 2027-05-27 Drug substance, Drug product 2024-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218591-001 10722471 2037-02-02 U-3896 Drug product 2024-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218591-002 8101659 2025-01-15 Drug product 2024-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218591-002 9388134 2026-11-08 U-1723 2024-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218591-002 8877938 2027-05-27 Drug substance, Drug product 2024-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218591-002 10722471 2037-02-02 U-3896 Drug product 2024-05-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218591-001 8101659 2025-01-15 Drug product 2024-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218591-001 9388134 2026-11-08 U-1723 2024-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218591-001 8877938 2027-05-27 Drug substance, Drug product 2024-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218591-001 10722471 2037-02-02 U-3896 Drug product 2024-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218591-002 8101659 2025-01-15 Drug product 2024-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218591-002 9388134 2026-11-08 U-1723 2024-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218591-002 8877938 2027-05-27 Drug substance, Drug product 2024-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218591-002 10722471 2037-02-02 U-3896 Drug product 2024-05-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218591-001 8101659 2025-01-15 Drug product 2024-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218591-001 9388134 2026-11-08 U-1723 2024-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218591-001 8877938 2027-05-27 Drug substance, Drug product 2024-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218591-001 10722471 2037-02-02 U-3896 Drug product 2024-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218591-002 8101659 2025-01-15 Drug product 2024-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218591-002 9388134 2026-11-08 U-1723 2024-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218591-002 8877938 2027-05-27 Drug substance, Drug product 2024-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218591-002 10722471 2037-02-02 U-3896 Drug product 2024-05-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218591-001 8101659 2025-01-15 Drug product 2024-05-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218591-001 9388134 2026-11-08 U-1723 2024-05-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218591-001 8877938 2027-05-27 Drug substance, Drug product 2024-05-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218591-001 10722471 2037-02-02 U-3896 Drug product 2024-05-08 b8a1b40f171c…
Additional Listing Data#
Finished product Yes
Brand name base ENTRESTO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SACUBITRIL 6 mg/1 VALSARTAN 6 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 80M03YXJ7I Internal UNII lookup 17ERJ0MKGI 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0078-1231-20 ENTRESTO 60 in 1 BOTTLE PELLET 60 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 0078-1231 ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED ENTRESTO (SACUBITRIL AND VALSARTAN) PELLET [NOVARTIS PHARMACEUTICALS CORPORATION] 22 Current NDC, 1 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 · 1 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): 218591 application number: NDA218591 ndc (product): 0078-1231
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0078-1231-20 00078123120 60 PELLET in 1 BOTTLE (0078-1231-20) 60 pellet 2024-04-12 No No Current