FDA.reportPublic FDA data

Sacubitril and Valsartan

Product NDC
82293-028
11-digit product format
822930028
Labeler code
82293
Product ID
82293-028_4d34c331-a1f9-937a-e063-6294a90a66b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sacubitril and Valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novugen Pharma (USA) LLC
Application
ANDA213611
Marketing category
ANDA
Marketing start
2025-07-16
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A213611-001SACUBITRIL AND VALSARTANSACUBITRIL; VALSARTAN24MG;26MGTABLET / ORALAB2025-07-16
A213611-002SACUBITRIL AND VALSARTANSACUBITRIL; VALSARTAN49MG;51MGTABLET / ORALAB2025-07-16
A213611-003SACUBITRIL 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
A213611-001AB
A213611-002AB
A213611-003AB

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
2026-08-01 22:54:322026-06A213611-001SACUBITRIL AND VALSARTAN24MG;26MGTABLET / ORALAB2025-07-16a50c72e98297…
2026-08-01 22:54:322026-06A213611-002SACUBITRIL AND VALSARTAN49MG;51MGTABLET / ORALAB2025-07-16a50c72e98297…
2026-08-01 22:54:322026-06A213611-003SACUBITRIL AND VALSARTAN97MG;103MGTABLET / ORALAB2025-07-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A213611-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A213611-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A213611-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sacubitril and ValsartanSACUBITRIL AND VALSARTANAmerican Health Packagingd85015d5-f619-4a58-b6ab-5e39af3f79d82026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213611
application number: ANDA213611
Sacubitril and ValsartanSACUBITRIL AND VALSARTANNovugen Pharma (USA) LLC747eeb5c-ac2f-474f-b6d2-0586d12653a62026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213611
application number: ANDA213611
ndc (product): 82293-028
Sacubitril and ValsartanSACUBITRIL AND VALSARTANNovugen Pharma (USA) LLCec37696b-eaac-4c74-9328-94857ce998e52025-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213611
application number: ANDA213611

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
747eeb5c-ac2f-474f-b6d2-0586d12653a6Available 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
82293-028-10Sacubitril and Valsartan60 in 1 BOTTLETABLET, FILM COATED602
82293-028-20Sacubitril and Valsartan180 in 1 BOTTLETABLET, FILM COATED1802
82293-028-30Sacubitril and Valsartan100 in 1 BOX, UNIT-DOSETABLET, FILM COATED1002
82293-028-31Sacubitril and Valsartan10 in 1 BLISTER PACKTABLET, FILM COATED102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82293-028-10EA - Each82293-028c79db7ef-6cf9-4f85-beba-44537002412a12025-09-12
82293-028-20EA - Each82293-0281f8f3ce9-93f1-4fb7-92c5-a6bb72eb1e4c12025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletPSN747eeb5c-ac2f-474f-b6d2-0586d12653a62
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletPSN747eeb5c-ac2f-474f-b6d2-0586d12653a62
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletPSN747eeb5c-ac2f-474f-b6d2-0586d12653a62
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletSCD747eeb5c-ac2f-474f-b6d2-0586d12653a62
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletSCD747eeb5c-ac2f-474f-b6d2-0586d12653a62
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletSCD747eeb5c-ac2f-474f-b6d2-0586d12653a62
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletPSNd85015d5-f619-4a58-b6ab-5e39af3f79d81
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletPSNd85015d5-f619-4a58-b6ab-5e39af3f79d81
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletPSNd85015d5-f619-4a58-b6ab-5e39af3f79d81
1656340sacubitril 24 MG / valsartan 26 MG Oral TabletSCDd85015d5-f619-4a58-b6ab-5e39af3f79d81
1656349sacubitril 49 MG / valsartan 51 MG Oral TabletSCDd85015d5-f619-4a58-b6ab-5e39af3f79d81
1656354sacubitril 97 MG / valsartan 103 MG Oral TabletSCDd85015d5-f619-4a58-b6ab-5e39af3f79d81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82293-028-108229300281060 TABLET, FILM COATED in 1 BOTTLE (82293-028-10) 2025-07-16NoNoCurrent
82293-028-2082293002820180 TABLET, FILM COATED in 1 BOTTLE (82293-028-20) 2025-07-16NoNoCurrent
82293-028-3082293002830100 BLISTER PACK in 1 BOX, UNIT-DOSE (82293-028-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK (82293-028-31) 100 blister pack2025-07-16NoNoCurrent
82293-028-318229300283110 in 1 BLISTER PACKHistorical