Home NDC 0904-7581 Sacubitril and Valsartan
Product NDC 0904-7581
11-digit product format 009047581
Labeler code 0904
Product ID 0904-7581_f2cba3db-0256-422a-a8a4-7afb3a9970d0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sacubitril and Valsartan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA213764
Marketing category ANDA
Marketing start 2025-11-03
Substance SACUBITRIL; VALSARTAN
Active strength 97; 103 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 43 .
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 A213764-001 SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-09-16 A213764-002 SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-09-16 A213764-003 SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-09-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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.
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 2026-09-14 22:38:34 2026-08 A213764-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-09-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213764-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-09-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213764-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-09-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213764-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213764-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213764-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-09-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213764-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213764-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213764-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-09-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213764-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213764-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213764-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-09-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213764-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213764-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213764-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-09-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213764-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213764-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213764-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-09-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213764-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213764-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213764-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-09-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213764-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213764-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213764-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-09-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213764-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213764-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213764-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-09-16 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213764-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-09-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213764-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-09-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213764-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-09-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213764-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-09-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213764-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-09-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213764-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-09-16 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213764-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-09-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213764-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-09-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213764-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-09-16 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Sacubitril and Valsartan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SACUBITRIL 97 mg/1 VALSARTAN 103 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1656340 Internal RxNorm lookup 1656349 Internal RxNorm lookup 1656354 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 0904-7581-04 Sacubitril and Valsartan 30 in 1 CARTON TABLET, FILM COATED 30 1 0904-7581-04 Sacubitril and Valsartan 1 in 1 BLISTER PACK TABLET, FILM COATED 1 1
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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sacubitril and Valsartan SACUBITRIL AND VALSARTAN Major Pharmaceuticals f2cba3db-0256-422a-a8a4-7afb3a9970d0 2025-10-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213764 application number: ANDA213764 ndc (product): 0904-7581 Sacubitril and Valsartan SACUBITRIL AND VALSARTAN Ascend Laboratories, LLC a0f23b69-5a1b-4aa8-8f0c-5818bd609492 2025-07-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213764 application number: ANDA213764 Sacubitril and Valsartan SACUBITRIL AND VALSARTAN Ascend Laboratories, LLC 98d838f6-03a9-43e9-b8dd-8882c6df1631 2025-07-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213764 application number: ANDA213764
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0904-7581-04 00904758104 30 BLISTER PACK in 1 CARTON (0904-7581-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK 30 blister pack 2025-11-03 No No Current