FDA.reportPublic FDA data

Sacubitril and Valsartan

Product NDC
70377-032
Requested package NDC
70377-032-11
11-digit product format
703770032
Labeler code
70377
Product ID
70377-032_646f3b67-93b9-d084-fafc-40f726e960c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sacubitril and Valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Biocon Pharma Inc.
Application
ANDA213680
Marketing category
ANDA
Marketing start
2025-07-17
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

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
A213680-001SACUBITRIL AND VALSARTANSACUBITRIL; VALSARTAN24MG;26MGTABLET / ORALAB2024-08-30
A213680-002SACUBITRIL AND VALSARTANSACUBITRIL; VALSARTAN49MG;51MGTABLET / ORALAB2024-08-30
A213680-003SACUBITRIL AND VALSARTANSACUBITRIL; VALSARTAN97MG;103MGTABLET / ORALAB2024-08-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213680-001AB
A213680-002AB
A213680-003AB

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
2026-11-14 07:37:172026-10A213680-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-30d4dbc9d85df4…
2026-11-14 07:37:172026-10A213680-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-08-30d4dbc9d85df4…
2026-11-14 07:37:172026-10A213680-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-08-30d4dbc9d85df4…
2026-10-15 13:18:302026-09A213680-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-30c2088c7a36db…
2026-10-15 13:18:302026-09A213680-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-08-30c2088c7a36db…
2026-10-15 13:18:302026-09A213680-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-08-30c2088c7a36db…
2026-09-14 22:38:342026-08A213680-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-3084e616aacf4f…
2026-09-14 22:38:342026-08A213680-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-08-3084e616aacf4f…
2026-09-14 22:38:342026-08A213680-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-08-3084e616aacf4f…
2026-08-18 06:07:402026-07A213680-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07A213680-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07A213680-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-08-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213680-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213680-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213680-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-08-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213680-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213680-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213680-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-08-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A213680-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213680-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213680-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-08-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213680-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213680-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213680-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-08-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213680-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213680-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213680-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-08-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213680-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213680-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213680-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-08-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213680-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213680-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213680-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-08-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213680-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213680-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-08-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213680-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-08-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213680-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213680-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-08-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213680-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-08-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213680-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-30d06236e962d9…

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
2026-11-14 07:37:172026-10A213680-001AB1d4dbc9d85df4…
2026-11-14 07:37:172026-10A213680-002AB1d4dbc9d85df4…
2026-11-14 07:37:172026-10A213680-003AB1d4dbc9d85df4…
2026-10-15 13:18:302026-09A213680-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A213680-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A213680-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A213680-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A213680-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A213680-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A213680-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213680-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213680-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213680-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213680-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213680-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213680-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213680-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213680-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213680-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213680-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213680-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213680-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213680-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213680-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213680-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213680-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213680-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213680-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213680-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213680-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213680-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213680-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213680-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213680-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213680-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213680-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213680-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213680-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213680-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213680-001AB1d06236e962d9…

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
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
17ERJ0MKGIInternal UNII lookup
80M03YXJ7IInternal 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
7de9b8e0-195a-b59e-7bbf-3e95c4096af9Available 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
70377-032-11Sacubitril and Valsartan30 in 1 BOTTLETABLET, FILM COATED305
70377-032-12Sacubitril and Valsartan60 in 1 BOTTLETABLET, FILM COATED605
70377-032-13Sacubitril and Valsartan180 in 1 BOTTLETABLET, FILM COATED1805
70377-032-14Sacubitril and Valsartan500 in 1 BOTTLETABLET, FILM COATED5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70377-032-12EA - Each70377-0329789e77c-7a98-43f2-a675-93cae117103012025-08-11
70377-032-13EA - Each70377-03244c85c23-13b2-4537-95c9-08f782be539c12025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletPSN7de9b8e0-195a-b59e-7bbf-3e95c4096af95
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletPSN7de9b8e0-195a-b59e-7bbf-3e95c4096af95
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletPSN7de9b8e0-195a-b59e-7bbf-3e95c4096af95
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletSCD7de9b8e0-195a-b59e-7bbf-3e95c4096af95
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletSCD7de9b8e0-195a-b59e-7bbf-3e95c4096af95
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletSCD7de9b8e0-195a-b59e-7bbf-3e95c4096af95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70377-032-117037700321130 TABLET, FILM COATED in 1 BOTTLE (70377-032-11) 2025-07-17NoNoCurrent