Home NDC 67877-949-33 Sacubitril and Valsartan
Product NDC 67877-949
Requested package NDC 67877-949-33
11-digit product format 678770949
Labeler code 67877
Product ID 67877-949_1e0bfd26-6750-468b-9812-dd017b4821dd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sacubitril and Valsartan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA213764
Marketing category ANDA
Marketing start 2025-07-23
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 2026-10-15 13:18:30 2026-09 A213764-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-09-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 A213764-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-09-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 A213764-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-09-16 c2088c7a36db…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 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 67877-949-33 Sacubitril and Valsartan 10 in 1 BLISTER PACK TABLET, FILM COATED 10 2 67877-949-33 Sacubitril and Valsartan 1 in 1 CARTON TABLET, FILM COATED 1 2 67877-949-51 Sacubitril and Valsartan 180 in 1 BOTTLE TABLET, FILM COATED 180 2 67877-949-60 Sacubitril and Valsartan 60 in 1 BOTTLE TABLET, FILM COATED 60 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 · 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 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 ndc (package): 67877-949-33 ndc (product): 67877-949 ndc11 (package): 67877094933 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 67877-949-33 67877094933 1 BLISTER PACK in 1 CARTON (67877-949-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2025-07-23 No No Current