Skip to content
MedsAcross

Medicine

Sacubitril and Valsartan 49 mg/51 mg tablet

Available on requestPrescription onlyUS FDAGeneric name

Sacubitril and Valsartan 49 mg/51 mg tablet is a generic prescription medicine for oral use, made by 25 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 25°C (77°F), excursions permitted between 15° and 30°C (59° and…

Key facts

Active ingredient (INN)
Sacubitril and Valsartan
Brand
Sold under the generic name
Strength
49 mg/51 mg
Dosage form
Tablet
Route
Oral
Packs
100 blister pack, 180 tablets, 60 tablets and 75 more
Manufacturers
Alembic PharmaceuticalsIndiaTorrent PharmaceuticalsIndiaZydus LifesciencesIndiaAscend LaboratoriesIndiaBioconIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaLaurus LabsIndia25 labelers on the register
Origin register
US FDA, United States
Storage
Store at 25°C (77°F), excursions permitted between 15° and 30°C (59° and 86°F). Protect from moisture.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
C09DX04 Sacubitril and Valsartan
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
16 October 2024
Identifiers
RxCUI 1656340, 1656349, 1656354DailyMed set ID 5928f174-83e5-4c74-b15a-138338a70295, a1fa7066-8ab4-47e3-a701-6c5170700d11, 43bcdbc7-a635-bb4e-e063-6294a90a990f +27NDC 62332-557, 70954-976, 73190-018 +28Application ANDA213682, ANDA213676, ANDA213605 +13

Record updated 12 November 2026

Documents available

Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.

No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.

Packs

A sample of 40 packs from 25 labelers. The register lists 78 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
100 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack46708-557-10Alembic PharmaceuticalsIndia4 November 2024
180 tablet, film coated in 1 bottle46708-557-45Alembic PharmaceuticalsIndia4 November 2024
60 tablet, film coated in 1 bottle46708-557-60Alembic PharmaceuticalsIndia4 November 2024
1000 tablet, film coated in 1 bottle46708-557-91Alembic PharmaceuticalsIndia4 November 2024
100 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack62332-557-10Alembic PharmaceuticalsIndia4 November 2024
180 tablet, film coated in 1 bottle62332-557-45Alembic PharmaceuticalsIndia4 November 2024
60 tablet, film coated in 1 bottle62332-557-60Alembic PharmaceuticalsIndia4 November 2024
1000 tablet, film coated in 1 bottle62332-557-91Alembic PharmaceuticalsIndia4 November 2024
180 tablet, film coated in 1 bottle67877-708-51Ascend LaboratoriesIndia23 July 2025
60 tablet, film coated in 1 bottle67877-708-60Ascend LaboratoriesIndia23 July 2025
1 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack67877-949-33Ascend LaboratoriesIndia23 July 2025
180 tablet, film coated in 1 bottle67877-949-51Ascend LaboratoriesIndia23 July 2025
60 tablet, film coated in 1 bottle67877-949-60Ascend LaboratoriesIndia23 July 2025
500 tablet in 1 bottle13668-635-05Torrent PharmaceuticalsIndia16 July 2025
180 tablet in 1 bottle13668-635-33Torrent PharmaceuticalsIndia16 July 2025
60 tablet in 1 bottle13668-635-60Torrent PharmaceuticalsIndia16 July 2025
100 blister pack in 1 carton / 10 tablet in 1 blister pack13668-635-74Torrent PharmaceuticalsIndia16 July 2025
500 tablet in 1 bottle13668-746-05Torrent PharmaceuticalsIndia16 July 2025
180 tablet in 1 bottle13668-746-33Torrent PharmaceuticalsIndia16 July 2025
60 tablet in 1 bottle13668-746-60Torrent PharmaceuticalsIndia16 July 2025
100 blister pack in 1 carton / 10 tablet in 1 blister pack13668-746-74Torrent PharmaceuticalsIndia16 July 2025
10 blister pack in 1 carton / 10 tablet in 1 blister pack70710-1273-4Zydus LifesciencesIndia8 July 2025
60 tablet in 1 bottle70710-1273-6Zydus LifesciencesIndia8 July 2025
180 tablet in 1 bottle70710-1273-8Zydus LifesciencesIndia8 July 2025
10 blister pack in 1 carton / 10 tablet in 1 blister pack70771-1922-4Zydus LifesciencesIndia8 July 2025
60 tablet in 1 bottle70771-1922-6Zydus LifesciencesIndia8 July 2025
180 tablet in 1 bottle70771-1922-8Zydus LifesciencesIndia8 July 2025
180 tablet, film coated in 1 bottle84386-082-18Aurobindo PharmaIndia26 October 2026
60 tablet, film coated in 1 bottle84386-082-60Aurobindo PharmaIndia26 October 2026
10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack84386-082-78Aurobindo PharmaIndia26 October 2026
30 tablet, film coated in 1 bottle70377-032-11BioconIndia17 July 2025
60 tablet, film coated in 1 bottle70377-032-12BioconIndia17 July 2025
180 tablet, film coated in 1 bottle70377-032-13BioconIndia17 July 2025
500 tablet, film coated in 1 bottle70377-032-14BioconIndia17 July 2025
180 tablet, film coated in 1 bottle31722-674-18Camber PharmaceuticalsIndia23 July 2025
60 tablet, film coated in 1 bottle31722-674-60Camber PharmaceuticalsIndia23 July 2025
180 tablet, film coated in 1 bottle43598-644-18Dr. Reddy's LaboratoriesIndia16 July 2025
60 tablet, film coated in 1 bottle43598-644-60Dr. Reddy's LaboratoriesIndia16 July 2025
180 tablet, film coated in 1 bottle42385-931-18Laurus LabsIndia11 November 2024
30 tablet, film coated in 1 bottle42385-931-30Laurus LabsIndia11 November 2024

Status by register

Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 7 July 2015Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Import route

Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.

Import guides are available for 25 countries. Pick one to see its route summary.

BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides

Alternatives

Other makers and brands of Sacubitril and Valsartan 49 mg/51 mg tablet.

Compare 1

Other strengths and forms of Sacubitril and Valsartan

Clinical summary

Sacubitril and Valsartan is a fixed-dose combination of an angiotensin 2 receptor blocker and a neprilysin inhibitor. It is available as tablets and oral pellets. MedsAcross supplies Sacubitril and Valsartan for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Sacubitril and Valsartan

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Sacubitril and Valsartan 49 mg/51 mg tablet for your hospital or patient?

Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.