FDA.reportPublic FDA data

Sacubitril and Valsartan

Product NDC
33342-571
11-digit product format
333420571
Labeler code
33342
Product ID
33342-571_103c39e2-f3c8-40fc-a57e-3af018fb4af4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sacubitril and Valsartan
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA213728
Marketing category
ANDA
Marketing start
2024-10-16
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213728-001SACUBITRIL AND VALSARTANSACUBITRIL; VALSARTAN24MG;26MGTABLET / ORALAB2024-10-16
A213728-002SACUBITRIL AND VALSARTANSACUBITRIL; VALSARTAN49MG;51MGTABLET / ORALAB2024-10-16
A213728-003SACUBITRIL AND VALSARTANSACUBITRIL; VALSARTAN97MG;103MGTABLET / ORALAB2024-10-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213728-001AB
A213728-002AB
A213728-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213728-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-10-1684e616aacf4f…
2026-09-14 22:38:342026-08A213728-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-10-1684e616aacf4f…
2026-09-14 22:38:342026-08A213728-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-10-1684e616aacf4f…
2026-08-18 06:07:402026-07A213728-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-10-16caaa826d4ba7…
2026-08-18 06:07:402026-07A213728-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-10-16caaa826d4ba7…
2026-08-18 06:07:402026-07A213728-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-10-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213728-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213728-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213728-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-10-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213728-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213728-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213728-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-10-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A213728-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213728-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213728-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-10-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213728-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213728-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213728-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-10-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213728-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213728-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213728-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-10-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213728-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213728-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213728-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-10-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213728-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-10-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213728-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-10-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213728-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-10-162680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213728-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-10-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213728-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-10-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213728-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-10-16d8e5a09893c0…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213728-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-10-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213728-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-10-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213728-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-10-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A213728-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A213728-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A213728-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A213728-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213728-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213728-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213728-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213728-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213728-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213728-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213728-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213728-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213728-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213728-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213728-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213728-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213728-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213728-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213728-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213728-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213728-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213728-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213728-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213728-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213728-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213728-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213728-003AB12680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213728-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213728-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213728-003AB1d8e5a09893c0…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213728-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213728-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213728-003AB1a50c72e98297…

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
IngredientStrength
SACUBITRIL49 mg/1
VALSARTAN51 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
80M03YXJ7IInternal UNII lookup
17ERJ0MKGIInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1656340Internal RxNorm lookup
1656349Internal RxNorm lookup
1656354Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
103c39e2-f3c8-40fc-a57e-3af018fb4af4Available on FDA.report

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-571-09Sacubitril and Valsartan60 in 1 BOTTLETABLET601
33342-571-57Sacubitril and Valsartan180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-571-09EA - Each33342-5716f0f1c2c-9ba2-4d65-9422-156393d7988812025-08-11
33342-571-57EA - Each33342-571d9d5d3c4-f98c-482f-87a8-c291507e98bc12025-08-11

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sacubitril and ValsartanSACUBITRIL AND VALSARTANNorthStar RxLLC998db1e1-3f32-4812-a64b-5a6870ef7f8f2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213728
application number: ANDA213728
Sacubitril and ValsartanSACUBITRIL AND VALSARTANXLCare Pharmaceuticals Inc064a7c51-de30-4759-8210-e18438e6a1872026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213728
application number: ANDA213728
Sacubitril and ValsartanSACUBITRIL AND VALSARTANAphena Pharma Solutions - Tennessee, LLC487102e3-f319-836b-e063-6394a90a44382026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213728
application number: ANDA213728
Sacubitril and ValsartanSACUBITRIL AND VALSARTANAphena Pharma Solutions - Tennessee, LLC4870fbeb-ce93-7953-e063-6294a90a61422026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213728
application number: ANDA213728
Sacubitril and ValsartanSACUBITRIL AND VALSARTANAphena Pharma Solutions - Tennessee, LLC48714b95-b4ac-ef3c-e063-6294a90a9a5b2026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213728
application number: ANDA213728
Sacubitril and ValsartanSACUBITRIL AND VALSARTANMacleods Pharmaceuticals Limited103c39e2-f3c8-40fc-a57e-3af018fb4af42025-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213728
application number: ANDA213728
ndc (product): 33342-571

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletPSN103c39e2-f3c8-40fc-a57e-3af018fb4af41
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletPSN103c39e2-f3c8-40fc-a57e-3af018fb4af41
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletPSN103c39e2-f3c8-40fc-a57e-3af018fb4af41
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletSCD103c39e2-f3c8-40fc-a57e-3af018fb4af41
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletSCD103c39e2-f3c8-40fc-a57e-3af018fb4af41
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletSCD103c39e2-f3c8-40fc-a57e-3af018fb4af41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-571-093334205710960 TABLET in 1 BOTTLE (33342-571-09) 60 tablet2024-10-16NoNoCurrent
33342-571-5733342057157180 TABLET in 1 BOTTLE (33342-571-57) 180 tablet2024-10-16NoNoCurrent