Home NDC 67046-1624 sacubitril and valsartan
Product NDC 67046-1624
11-digit product format 670461624
Labeler code 67046
Product ID 67046-1624_48c0e508-e68a-3d43-e063-6294a90a3ade
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sacubitril and valsartan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Coupler LLC
Application ANDA213682
Marketing category ANDA
Marketing start 2025-12-16
Substance SACUBITRIL; VALSARTAN
Active strength 24; 26 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 2027-12-31
Current FDA listing Yes 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 A213682-001 SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-05-28 A213682-002 SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-05-28 A213682-003 SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-05-28
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.
Product history page 1 of 2 · 42 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 A213682-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213682-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213682-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213682-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213682-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213682-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213682-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213682-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213682-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213682-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-05-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213682-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-05-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213682-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213682-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-05-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213682-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-05-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213682-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213682-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-05-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213682-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-05-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213682-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213682-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-05-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213682-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-05-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213682-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213682-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-05-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213682-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-05-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213682-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213682-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-05-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213682-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-05-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213682-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213682-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-05-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213682-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-05-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213682-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213682-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-05-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213682-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-05-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213682-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213682-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-05-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213682-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-05-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213682-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213682-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-05-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213682-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-05-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213682-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-05-28 1e350fbaab3a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213682-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-05-28 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base sacubitril and valsartan
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SACUBITRIL 24 mg/1 VALSARTAN 26 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1656340 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 67046-1624-3 sacubitril and valsartan 30 in 1 BLISTER PACK TABLET, FILM COATED 30 2
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 sacubitril and valsartan SACUBITRIL AND VALSARTAN Coupler LLC 46154d5f-7de1-db5e-e063-6394a90af86e 2026-01-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213682 application number: ANDA213682 ndc (product): 67046-1624 sacubitril and valsartan SACUBITRIL AND VALSARTAN Golden State Medical Supply, Inc. 8290ae4c-0d1e-47f6-8029-ddc1c0bd6f6d 2025-11-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213682 application number: ANDA213682 sacubitril and valsartan SACUBITRIL AND VALSARTAN Alembic Pharmaceuticals Inc. 5928f174-83e5-4c74-b15a-138338a70295 2024-11-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213682 application number: ANDA213682 sacubitril and valsartan SACUBITRIL AND VALSARTAN Alembic Pharmaceuticals Limited e4716fc9-5f73-4303-8a4e-e8f9129b6e2d 2024-11-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213682 application number: ANDA213682
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 67046-1624-3 67046162403 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1624-3) 2025-12-16 No No Current