FDA.reportPublic FDA data

sacubitril and valsartan

Product NDC
13668-636
11-digit product format
136680636
Labeler code
13668
Product ID
13668-636_3876b6f1-ea3c-4aa1-a1ee-876e32efc629
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sacubitril and valsartan
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA213604
Marketing category
ANDA
Marketing start
2025-07-16
Marketing end
2026-12-31
Substance
SACUBITRIL; VALSARTAN
Active strength
97; 103 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
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13668-636-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13668-636-33ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13668-636-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13668-636-74ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13668-636-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13668-636-33367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13668-636-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13668-636-74367a005e9d99…383a685ebd0f…

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
A213604-001SACUBITRIL AND VALSARTANSACUBITRIL; VALSARTAN24MG;26MGTABLET / ORALAB2024-08-22
A213604-002SACUBITRIL AND VALSARTANSACUBITRIL; VALSARTAN49MG;51MGTABLET / ORALAB2024-08-22
A213604-003SACUBITRIL AND VALSARTANSACUBITRIL; VALSARTAN97MG;103MGTABLET / ORALAB2024-08-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213604-001AB
A213604-002AB
A213604-003AB

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 22:38:342026-08A213604-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-2284e616aacf4f…
2026-09-14 22:38:342026-08A213604-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-08-2284e616aacf4f…
2026-09-14 22:38:342026-08A213604-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-08-2284e616aacf4f…
2026-08-18 06:07:402026-07A213604-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07A213604-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07A213604-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-08-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213604-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213604-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213604-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-08-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213604-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213604-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213604-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-08-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A213604-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213604-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213604-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-08-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213604-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213604-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213604-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-08-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213604-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213604-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-08-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213604-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-08-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213604-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213604-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-08-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213604-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-08-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213604-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213604-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-08-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213604-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-08-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213604-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213604-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-08-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213604-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-08-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213604-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213604-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-08-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213604-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-08-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213604-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORAL2024-08-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A213604-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORAL2024-08-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A213604-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORAL2024-08-22d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213604-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2024-08-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213604-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2024-08-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213604-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2024-08-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A213604-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A213604-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A213604-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A213604-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213604-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213604-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213604-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213604-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213604-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213604-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213604-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213604-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213604-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213604-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213604-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213604-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213604-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213604-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213604-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213604-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213604-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213604-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213604-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213604-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213604-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213604-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213604-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213604-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213604-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213604-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213604-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213604-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213604-003AB1d8e5a09893c0…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213604-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213604-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213604-003AB1a50c72e98297…

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SACUBITRIL97 mg/1
VALSARTAN103 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
59b7a07a-96ee-44b1-8dae-2b42169aa2c5Available 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
13668-636-05sacubitril and valsartan500 in 1 BOTTLETABLET50012
13668-636-33sacubitril and valsartan180 in 1 BOTTLETABLET18012
13668-636-60sacubitril and valsartan60 in 1 BOTTLETABLET6012
13668-636-71sacubitril and valsartan10 in 1 BLISTER PACKTABLET1012
13668-636-74sacubitril and valsartan100 in 1 CARTONTABLET10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-636-33EA - Each13668-636748732ec-74a0-44ee-8bb0-c495b5ac3ddc12025-08-11
13668-636-60EA - Each13668-636be07a9ce-f3f2-48c7-89f3-55de5b65af2912025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-636SACUBITRIL AND VALSARTAN TABLET [TORRENT PHARMACEUTICALS LIMITED]10Current NDC, 5 package rows20241211_59b7a07a-96ee-44b1-8dae-2b42169aa2c5.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sacubitril and valsartanSACUBITRIL AND VALSARTANTorrent Pharmaceuticals Limited59b7a07a-96ee-44b1-8dae-2b42169aa2c52026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213604
application number: ANDA213604
ndc (product): 13668-636

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletPSN59b7a07a-96ee-44b1-8dae-2b42169aa2c512
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletPSN59b7a07a-96ee-44b1-8dae-2b42169aa2c512
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletPSN59b7a07a-96ee-44b1-8dae-2b42169aa2c512
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletSCD59b7a07a-96ee-44b1-8dae-2b42169aa2c512
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletSCD59b7a07a-96ee-44b1-8dae-2b42169aa2c512
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletSCD59b7a07a-96ee-44b1-8dae-2b42169aa2c512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-636-0513668063605500 TABLET in 1 BOTTLE (13668-636-05) 500 tablet2025-07-162026-12-31NoNoHistorical
13668-636-3313668063633180 TABLET in 1 BOTTLE (13668-636-33) 180 tablet2025-07-162026-12-31NoNoHistorical
13668-636-601366806366060 TABLET in 1 BOTTLE (13668-636-60) 60 tablet2025-07-162026-12-31NoNoHistorical
13668-636-711366806367110 in 1 BLISTER PACKHistorical
13668-636-7413668063674100 BLISTER PACK in 1 CARTON (13668-636-74) / 10 TABLET in 1 BLISTER PACK (13668-636-71) 100 blister pack2025-07-162026-12-31NoNoHistorical