FDA.reportPublic FDA data

Sacubitril and Valsartan

Product NDC
73190-005
Requested package NDC
73190-005-60
11-digit product format
731900005
Labeler code
73190
Product ID
73190-005_4c260039-9848-e878-e063-6294a90a3dcb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sacubitril and Valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA213748
Marketing category
ANDA
Marketing start
2025-01-21
Substance
SACUBITRIL; VALSARTAN
Active strength
24; 26 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 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
A213748-001SACUBITRIL AND VALSARTANSACUBITRIL; VALSARTAN24MG;26MGTABLET / ORALAB2025-07-16
A213748-002SACUBITRIL AND VALSARTANSACUBITRIL; VALSARTAN49MG;51MGTABLET / ORALAB2025-07-16
A213748-003SACUBITRIL AND VALSARTANSACUBITRIL; VALSARTAN97MG;103MGTABLET / ORALAB2025-07-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213748-001AB
A213748-002AB
A213748-003AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213748-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2025-07-1684e616aacf4f…
2026-09-14 22:38:342026-08A213748-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2025-07-1684e616aacf4f…
2026-09-14 22:38:342026-08A213748-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2025-07-1684e616aacf4f…
2026-08-18 06:07:402026-07A213748-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2025-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07A213748-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2025-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07A213748-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2025-07-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213748-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2025-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213748-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2025-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213748-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2025-07-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213748-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2025-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213748-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2025-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213748-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2025-07-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A213748-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2025-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213748-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2025-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213748-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2025-07-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213748-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-07-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213748-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-07-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213748-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-07-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213748-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-07-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213748-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-07-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213748-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-07-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213748-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-07-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213748-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-07-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213748-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-07-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213748-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-07-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213748-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-07-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213748-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-07-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213748-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-07-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213748-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-07-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213748-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-07-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213748-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-07-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213748-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-07-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213748-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-07-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213748-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-07-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A213748-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-07-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A213748-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-07-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213748-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-07-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213748-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-07-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213748-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-07-2479d66fd596c7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213748-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2025-07-16a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A213748-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A213748-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A213748-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A213748-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213748-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213748-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213748-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213748-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213748-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213748-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213748-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213748-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213748-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213748-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213748-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213748-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213748-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213748-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213748-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213748-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213748-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213748-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213748-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213748-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213748-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213748-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213748-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213748-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213748-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213748-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213748-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213748-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213748-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213748-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213748-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213748-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213748-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213748-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213748-003AB179d66fd596c7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213748-001AB1a50c72e98297…

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
IngredientStrength
SACUBITRIL24 mg/1
VALSARTAN26 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
2c39c326-34a2-b7f4-e063-6294a90a6732Available 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
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73190-005-10Sacubitril and Valsartan1000 in 1 BOTTLETABLET, FILM COATED10004
73190-005-18Sacubitril and Valsartan180 in 1 BOTTLETABLET, FILM COATED1804
73190-005-60Sacubitril and Valsartan60 in 1 BOTTLETABLET, FILM COATED604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73190-005-10EA - Each73190-0051dc117b3-a8d7-4a59-9b64-17b7c8a1c9c912026-04-20
73190-005-18EA - Each73190-0056446ccd9-8fab-4c97-8d98-e5313928c51912025-02-10
73190-005-60EA - Each73190-0057611cbab-501a-4127-9fce-24544ea4e75512025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73190-005SACUBITRIL AND VALSARTAN TABLET, FILM COATED [AVKARE]1Current NDC, 3 package rows20250122_2c39c326-34a2-b7f4-e063-6294a90a6732.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sacubitril and ValsartanSACUBITRIL AND VALSARTANAvKARE2c39c326-34a2-b7f4-e063-6294a90a67322026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213748
application number: ANDA213748
ndc (package): 73190-005-60
ndc (product): 73190-005
ndc11 (package): 73190000560
Sacubitril and ValsartanSACUBITRIL AND VALSARTANAphena Pharma Solutions - Tennessee, LLC4134afd2-a0a0-a64a-e063-6394a90ae5802025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213748
application number: ANDA213748
Sacubitril and ValsartanSACUBITRIL AND VALSARTANAvPAK4114a976-2e58-8437-e063-6394a90af2982025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213748
application number: ANDA213748
Sacubitril and ValsartanSACUBITRIL AND VALSARTANAphena Pharma Solutions - Tennessee, LLC3cf9da3f-42b7-df11-e063-6294a90ad40b2025-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213748
application number: ANDA213748
Sacubitril and ValsartanSACUBITRIL AND VALSARTANAphena Pharma Solutions - Tennessee, LLC3cfa68eb-6167-e7ed-e063-6294a90a27f62025-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213748
application number: ANDA213748
Sacubitril and ValsartanSACUBITRIL AND VALSARTANNovadoz Pharmaceuticals LLC44db8114-622e-41f6-96a1-447d47b0267c2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213748
application number: ANDA213748

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletPSN2c39c326-34a2-b7f4-e063-6294a90a67324
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletPSN2c39c326-34a2-b7f4-e063-6294a90a67324
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletPSN2c39c326-34a2-b7f4-e063-6294a90a67324
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletSCD2c39c326-34a2-b7f4-e063-6294a90a67324
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletSCD2c39c326-34a2-b7f4-e063-6294a90a67324
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletSCD2c39c326-34a2-b7f4-e063-6294a90a67324
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletPSN3cfa68eb-6167-e7ed-e063-6294a90a27f62
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletSCD3cfa68eb-6167-e7ed-e063-6294a90a27f62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73190-005-607319000056060 TABLET, FILM COATED in 1 BOTTLE (73190-005-60) 2025-01-21NoNoCurrent