Sacubitril and Valsartan

Product NDC: 71610-939
Requested package NDC: 71610-939-32
11-digit product format: 716100939
Labeler code: 71610
Product ID: 71610-939_3dd750a5-346a-e671-e063-6394a90a9cf4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sacubitril and Valsartan
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA213748
Marketing category: ANDA
Marketing start: 2025-01-21
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: 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	Approval date
A213748-001	SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	24MG;26MG	TABLET / ORAL	AB	2025-07-16
A213748-002	SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	49MG;51MG	TABLET / ORAL	AB	2025-07-16
A213748-003	SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	97MG;103MG	TABLET / ORAL	AB	2025-07-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A213748-001	AB
A213748-002	AB
A213748-003	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
2026-09-14 22:38:34	2026-08	A213748-001	SACUBITRIL AND VALSARTAN	24MG;26MG	TABLET / ORAL	AB	2025-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213748-002	SACUBITRIL AND VALSARTAN	49MG;51MG	TABLET / ORAL	AB	2025-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213748-003	SACUBITRIL AND VALSARTAN	97MG;103MG	TABLET / ORAL	AB	2025-07-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213748-001	SACUBITRIL AND VALSARTAN	24MG;26MG	TABLET / ORAL	AB	2025-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213748-002	SACUBITRIL AND VALSARTAN	49MG;51MG	TABLET / ORAL	AB	2025-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213748-003	SACUBITRIL AND VALSARTAN	97MG;103MG	TABLET / ORAL	AB	2025-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213748-001	SACUBITRIL AND VALSARTAN	24MG;26MG	TABLET / ORAL	AB	2025-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213748-002	SACUBITRIL AND VALSARTAN	49MG;51MG	TABLET / ORAL	AB	2025-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213748-003	SACUBITRIL AND VALSARTAN	97MG;103MG	TABLET / ORAL	AB	2025-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213748-001	SACUBITRIL AND VALSARTAN	24MG;26MG	TABLET / ORAL	AB	2025-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213748-002	SACUBITRIL AND VALSARTAN	49MG;51MG	TABLET / ORAL	AB	2025-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213748-003	SACUBITRIL AND VALSARTAN	97MG;103MG	TABLET / ORAL	AB	2025-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213748-001	SACUBITRIL AND VALSARTAN	24MG;26MG	TABLET / ORAL	AB	2025-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213748-002	SACUBITRIL AND VALSARTAN	49MG;51MG	TABLET / ORAL	AB	2025-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213748-003	SACUBITRIL AND VALSARTAN	97MG;103MG	TABLET / ORAL	AB	2025-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213748-001	SACUBITRIL AND VALSARTAN	24MG;26MG	TABLET / ORAL	AB	2024-07-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213748-002	SACUBITRIL AND VALSARTAN	49MG;51MG	TABLET / ORAL	AB	2024-07-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213748-003	SACUBITRIL AND VALSARTAN	97MG;103MG	TABLET / ORAL	AB	2024-07-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213748-001	SACUBITRIL AND VALSARTAN	24MG;26MG	TABLET / ORAL	AB	2024-07-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213748-002	SACUBITRIL AND VALSARTAN	49MG;51MG	TABLET / ORAL	AB	2024-07-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213748-003	SACUBITRIL AND VALSARTAN	97MG;103MG	TABLET / ORAL	AB	2024-07-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213748-001	SACUBITRIL AND VALSARTAN	24MG;26MG	TABLET / ORAL	AB	2024-07-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213748-002	SACUBITRIL AND VALSARTAN	49MG;51MG	TABLET / ORAL	AB	2024-07-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213748-003	SACUBITRIL AND VALSARTAN	97MG;103MG	TABLET / ORAL	AB	2024-07-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213748-001	SACUBITRIL AND VALSARTAN	24MG;26MG	TABLET / ORAL	AB	2024-07-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213748-002	SACUBITRIL AND VALSARTAN	49MG;51MG	TABLET / ORAL	AB	2024-07-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213748-003	SACUBITRIL AND VALSARTAN	97MG;103MG	TABLET / ORAL	AB	2024-07-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213748-001	SACUBITRIL AND VALSARTAN	24MG;26MG	TABLET / ORAL	AB	2024-07-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213748-002	SACUBITRIL AND VALSARTAN	49MG;51MG	TABLET / ORAL	AB	2024-07-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213748-003	SACUBITRIL AND VALSARTAN	97MG;103MG	TABLET / ORAL	AB	2024-07-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213748-001	SACUBITRIL AND VALSARTAN	24MG;26MG	TABLET / ORAL	AB	2024-07-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213748-002	SACUBITRIL AND VALSARTAN	49MG;51MG	TABLET / ORAL	AB	2024-07-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213748-003	SACUBITRIL AND VALSARTAN	97MG;103MG	TABLET / ORAL	AB	2024-07-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213748-001	SACUBITRIL AND VALSARTAN	24MG;26MG	TABLET / ORAL	AB	2024-07-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213748-002	SACUBITRIL AND VALSARTAN	49MG;51MG	TABLET / ORAL	AB	2024-07-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213748-003	SACUBITRIL AND VALSARTAN	97MG;103MG	TABLET / ORAL	AB	2024-07-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213748-001	SACUBITRIL AND VALSARTAN	24MG;26MG	TABLET / ORAL	AB	2024-07-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213748-002	SACUBITRIL AND VALSARTAN	49MG;51MG	TABLET / ORAL	AB	2024-07-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213748-003	SACUBITRIL AND VALSARTAN	97MG;103MG	TABLET / ORAL	AB	2024-07-24	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213748-001	SACUBITRIL AND VALSARTAN	24MG;26MG	TABLET / ORAL	AB	2025-07-16	`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
2026-09-14 22:38:34	2026-08	A213748-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213748-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213748-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213748-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213748-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213748-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213748-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213748-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213748-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213748-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213748-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213748-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213748-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213748-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213748-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213748-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213748-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213748-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213748-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213748-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213748-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213748-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213748-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213748-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213748-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213748-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213748-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213748-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213748-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213748-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213748-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213748-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213748-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213748-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213748-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213748-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213748-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213748-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213748-003	AB	1	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213748-001	AB	1	`a50c72e98297…`

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	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1656349	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
3cf9da3f-42b7-df11-e063-6294a90ad40b	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	Strength	SPL version
71610-939-32	Sacubitril and Valsartan	780 in 1 BOTTLE	TABLET, FILM COATED	780		2
71610-939-89	Sacubitril and Valsartan	720 in 1 BOTTLE	TABLET, FILM COATED	720		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-939-32	EA - Each	71610-939	887650bc-fef5-4e5a-8044-8898acbb5323	1	2025-10-14
71610-939-89	EA - Each	71610-939	6316f8f4-1b97-41cc-b4b2-0ce2be0d2676	1	2025-10-14

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sacubitril and Valsartan	SACUBITRIL AND VALSARTAN	AvKARE	2c39c326-34a2-b7f4-e063-6294a90a6732	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213748 application number: ANDA213748
Sacubitril and Valsartan	SACUBITRIL AND VALSARTAN	Aphena Pharma Solutions - Tennessee, LLC	4134afd2-a0a0-a64a-e063-6394a90ae580	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213748 application number: ANDA213748
Sacubitril and Valsartan	SACUBITRIL AND VALSARTAN	AvPAK	4114a976-2e58-8437-e063-6394a90af298	2025-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213748 application number: ANDA213748
Sacubitril and Valsartan	SACUBITRIL AND VALSARTAN	Aphena Pharma Solutions - Tennessee, LLC	3cf9da3f-42b7-df11-e063-6294a90ad40b	2025-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213748 application number: ANDA213748 ndc (package): 71610-939-32 ndc (product): 71610-939 ndc11 (package): 71610093932
Sacubitril and Valsartan	SACUBITRIL AND VALSARTAN	Aphena Pharma Solutions - Tennessee, LLC	3cfa68eb-6167-e7ed-e063-6294a90a27f6	2025-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213748 application number: ANDA213748
Sacubitril and Valsartan	SACUBITRIL AND VALSARTAN	Novadoz Pharmaceuticals LLC	44db8114-622e-41f6-96a1-447d47b0267c	2025-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213748 application number: ANDA213748

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
1656349	sacubitril 49 MG / valsartan 51 MG Oral Tablet	PSN	3cf9da3f-42b7-df11-e063-6294a90ad40b	2
1656349	sacubitril 49 MG / valsartan 51 MG Oral Tablet	SCD	3cf9da3f-42b7-df11-e063-6294a90ad40b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71610-939-32	71610093932	780 TABLET, FILM COATED in 1 BOTTLE (71610-939-32)	2025-09-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sacubitril and Valsartan	Aphena Pharma Solutions - Tennessee, LLC	2025-09-02	HUMAN PRESCRIPTION DRUG LABEL	2