Sacubitril and Valsartan Tablets

Manufacturer
Zydus Lifesciences Limited
Effective date
2025-07-08
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 21:37:03

Label at a glance#

Productsacubitril and valsartan
Active ingredientSACUBITRIL, VALSARTAN
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1921-6

Sacubitril and valsartan tablets, 24 mg/26 mg

60 Tablets

Rx only

24 mg / 26 mg
24 mg / 26 mg

NDC 70771-1922-6

Sacubitril and valsartan tablets, 49 mg/51 mg

60 Tablets

Rx only

49 mg/51 mg
49 mg/51 mg

NDC 70771-1923-6

Sacubitril and valsartan tablets, 97 mg/103 mg

60 Tablets

Rx only

97 mg/103 mg
97 mg/103 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletPSN1
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletPSN1
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletPSN1
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletSCD1
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletSCD1
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
SACUBITRILAT Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
VALSARTAN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
692a3434-fece-49c6-9b7d-ed7aefc52b50Product name320260317
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
e7dfdaab-7cf9-4f89-804c-eff5108d94d1Product name920250305
b6abae2f-ee27-47bc-b150-54dc8d969483Product name220250221
52311e76-a520-4bd2-9d5b-e0b6d6f44519Product name220231208
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1921-2sacubitril and valsartan10 in 1 BLISTER PACKTABLET101
70771-1921-4sacubitril and valsartan10 in 1 CARTONTABLET101
70771-1921-6sacubitril and valsartan60 in 1 BOTTLETABLET601
70771-1921-8sacubitril and valsartan180 in 1 BOTTLETABLET1801
70771-1922-2sacubitril and valsartan10 in 1 BLISTER PACKTABLET101
70771-1922-4sacubitril and valsartan10 in 1 CARTONTABLET101
70771-1922-6sacubitril and valsartan60 in 1 BOTTLETABLET601
70771-1922-8sacubitril and valsartan180 in 1 BOTTLETABLET1801
70771-1923-2sacubitril and valsartan10 in 1 BLISTER PACKTABLET101
70771-1923-4sacubitril and valsartan10 in 1 CARTONTABLET101
70771-1923-6sacubitril and valsartan60 in 1 BOTTLETABLET601
70771-1923-8sacubitril and valsartan180 in 1 BOTTLETABLET1801

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213719-001SACUBITRIL AND VALSARTANSACUBITRIL; VALSARTAN24MG;26MGTABLET / ORALAB2024-07-09
A213719-002SACUBITRIL AND VALSARTANSACUBITRIL; VALSARTAN49MG;51MGTABLET / ORALAB2024-07-09
A213719-003SACUBITRIL AND VALSARTANSACUBITRIL; VALSARTAN97MG;103MGTABLET / ORALAB2024-07-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213719-001AB
A213719-002AB
A213719-003AB

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 · 45 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213719-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-07-0984e616aacf4f…
2026-09-14 22:38:342026-08A213719-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-07-0984e616aacf4f…
2026-09-14 22:38:342026-08A213719-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-07-0984e616aacf4f…
2026-08-18 06:07:402026-07A213719-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07A213719-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07A213719-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-07-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213719-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213719-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213719-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-07-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213719-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213719-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213719-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-07-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A213719-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213719-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213719-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-07-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213719-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213719-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213719-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-07-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213719-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213719-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213719-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-07-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213719-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213719-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213719-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-07-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213719-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213719-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213719-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-07-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213719-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-07-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213719-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-07-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213719-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-07-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213719-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-07-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213719-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-07-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213719-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-07-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213719-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-07-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A213719-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-07-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A213719-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-07-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213719-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-07-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213719-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-07-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213719-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-07-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213719-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-07-09301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A213719-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A213719-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A213719-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A213719-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213719-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213719-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213719-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213719-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213719-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213719-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213719-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213719-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213719-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213719-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213719-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213719-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213719-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213719-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213719-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213719-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213719-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213719-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213719-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213719-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213719-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213719-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213719-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213719-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213719-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213719-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213719-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213719-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213719-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213719-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213719-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213719-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213719-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213719-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213719-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213719-001AB1301d65b070ca…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sacubitril and valsartanSACUBITRIL AND VALSARTANZydus Lifesciences Limited4c871c01-0564-411f-87e2-478aa42503cf2025-07-08Exact identifier
ndc (package): 70771-1923-6
ndc (package): 70771-1923-4
ndc (package): 70771-1921-4
ndc (package): 70771-1921-6
ndc (package): 70771-1921-2
ndc (package): 70771-1923-2
ndc (package): 70771-1922-2
ndc (package): 70771-1921-8
ndc (package): 70771-1922-6
ndc (package): 70771-1923-8
ndc (package): 70771-1922-4
ndc (package): 70771-1922-8
ndc (product): 70771-1921
ndc (product): 70771-1923
ndc (product): 70771-1922
ndc11 (package): 70771192204
ndc11 (package): 70771192306
ndc11 (package): 70771192104
ndc11 (package): 70771192304
ndc11 (package): 70771192208
ndc11 (package): 70771192302
ndc11 (package): 70771192202
ndc11 (package): 70771192102
ndc11 (package): 70771192108
ndc11 (package): 70771192206
ndc11 (package): 70771192106
ndc11 (package): 70771192308
spl id: f0d8c298-2823-4537-ae02-c43da2c66e67
spl set id: 4c871c01-0564-411f-87e2-478aa42503cf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.