sacubitril and valsartan

Product NDC: 46708-558
Requested package NDC: 46708-558-91
11-digit product format: 467080558
Labeler code: 46708
Product ID: 46708-558_e4716fc9-5f73-4303-8a4e-e8f9129b6e2d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sacubitril and valsartan
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA213682
Marketing category: ANDA
Marketing start: 2024-11-04
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 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	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.

Application-product, TE code table
Application-product	TE code
A213682-001	AB
A213682-002	AB
A213682-003	AB

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213682-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213682-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213682-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213682-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213682-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213682-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213682-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213682-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213682-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213682-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213682-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213682-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213682-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213682-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213682-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213682-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213682-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213682-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213682-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213682-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213682-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213682-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213682-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213682-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213682-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213682-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213682-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213682-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213682-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213682-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213682-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213682-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213682-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213682-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213682-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213682-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213682-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213682-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213682-003	AB	1	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213682-001	AB	1	`a50c72e98297…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e4716fc9-5f73-4303-8a4e-e8f9129b6e2d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
692a3434-fece-49c6-9b7d-ed7aefc52b50	Product name	3	20260317
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
265792b3-b999-c010-7364-a7db20b9d4d9	Product name	5	20250515
e7dfdaab-7cf9-4f89-804c-eff5108d94d1	Product name	9	20250305
b6abae2f-ee27-47bc-b150-54dc8d969483	Product name	2	20250221
52311e76-a520-4bd2-9d5b-e0b6d6f44519	Product name	2	20231208
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
f5231d08-c52b-a5a0-ba93-675895c292be	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
46708-558-10	sacubitril and valsartan	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	1
46708-558-10	sacubitril and valsartan	100 in 1 CARTON	TABLET, FILM COATED	100	1
46708-558-45	sacubitril and valsartan	180 in 1 BOTTLE	TABLET, FILM COATED	180	1
46708-558-60	sacubitril and valsartan	60 in 1 BOTTLE	TABLET, FILM COATED	60	1
46708-558-91	sacubitril and valsartan	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-558	SACUBITRIL AND VALSARTAN TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]	1	Current NDC, 5 package rows	20241105_e4716fc9-5f73-4303-8a4e-e8f9129b6e2d.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
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
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 ndc (package): 46708-558-91 ndc (product): 46708-558 ndc11 (package): 46708055891

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
17ERJ0MKGI	SACUBITRIL	149709-62-6	SACUBITRIL
80M03YXJ7I	VALSARTAN	137862-53-4	VALSARTAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1656340	sacubitril 24 MG / valsartan 26 MG Oral Tablet	PSN	e4716fc9-5f73-4303-8a4e-e8f9129b6e2d	1
1656349	sacubitril 49 MG / valsartan 51 MG Oral Tablet	PSN	e4716fc9-5f73-4303-8a4e-e8f9129b6e2d	1
1656354	sacubitril 97 MG / valsartan 103 MG Oral Tablet	PSN	e4716fc9-5f73-4303-8a4e-e8f9129b6e2d	1
1656340	sacubitril 24 MG / valsartan 26 MG Oral Tablet	SCD	e4716fc9-5f73-4303-8a4e-e8f9129b6e2d	1
1656349	sacubitril 49 MG / valsartan 51 MG Oral Tablet	SCD	e4716fc9-5f73-4303-8a4e-e8f9129b6e2d	1
1656354	sacubitril 97 MG / valsartan 103 MG Oral Tablet	SCD	e4716fc9-5f73-4303-8a4e-e8f9129b6e2d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
46708-558-91	46708055891	1000 TABLET, FILM COATED in 1 BOTTLE (46708-558-91)	2024-11-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
sacubitril and valsartan	Alembic Pharmaceuticals Limited	2024-11-03	Human Prescription Drug Label	1