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Medicine

Ivabradine 5 mg tablet

Ivabradine · Oral
Available on requestPrescription onlyUS FDAGeneric name

Ivabradine 5 mg tablet is a generic prescription medicine for oral use, made by 9 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 to 15°C to 30°C (59°F to 86°F)…

Key facts

Active ingredient (INN)
Ivabradine
Brand
Sold under the generic name
Strength
5 mg
Dosage form
Tablet
Route
Oral
Packs
180 tablets, 60 tablets, 500 tablets and 14 more
Manufacturers
Alembic PharmaceuticalsIndiaZydus LifesciencesIndiaNovadoz PharmaceuticalsIndiaCamber PharmaceuticalsIndiaBionpharmaAmerican Health PackagingGolden State Medical SupplyIngenus PharmaceuticalsNorthStar Rx
Origin register
US FDA, United States
Storage
Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store in the original bottle.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
C01EB17 Ivabradine
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
30 December 2021
Identifiers
RxCUI 1649485, 1649493DailyMed set ID 602d1c55-0e4d-452a-a087-888fdbaa7568, 53f15531-796d-442b-a73c-05f048218531, 5157767b-16d5-4a69-b6bd-95d360d19fda +8NDC 31722-053, 62332-679, 72603-934 +8Application ANDA213366, ANDA215238, ANDA213483 +3

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

Packs from every labeler of this generic presentation.

PackCodeLabelerMarketed since
180 tablet, film coated in 1 bottle46708-679-45Alembic PharmaceuticalsIndia20 December 2024
60 tablet, film coated in 1 bottle46708-679-60Alembic PharmaceuticalsIndia20 December 2024
180 tablet, film coated in 1 bottle62332-679-45Alembic PharmaceuticalsIndia20 December 2024
60 tablet, film coated in 1 bottle62332-679-60Alembic PharmaceuticalsIndia20 December 2024
60 tablet in 1 bottle70710-1471-6Zydus LifesciencesIndia2 July 2024
180 tablet in 1 bottle70710-1471-8Zydus LifesciencesIndia2 July 2024
60 tablet in 1 bottle70771-1863-6Zydus LifesciencesIndia2 July 2024
180 tablet in 1 bottle70771-1863-8Zydus LifesciencesIndia2 July 2024
60 tablet, film coated in 1 bottle31722-053-60Camber PharmaceuticalsIndia5 October 2022
180 tablet, film coated in 1 bottle72205-336-18Novadoz PharmaceuticalsIndia1 July 2025
60 tablet, film coated in 1 bottle72205-336-60Novadoz PharmaceuticalsIndia1 July 2025
60 tablet, film coated in 1 bottle69452-190-17Bionpharma1 March 2025
500 tablet, film coated in 1 bottle69452-190-30Bionpharma1 March 2025
60 tablet, film coated in 1 bottle50742-362-60Ingenus Pharmaceuticals15 July 2024
30 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack60687-862-21American Health Packaging1 July 2025
60 tablet, film coated in 1 bottle51407-592-60Golden State Medical Supply29 August 2024
60 tablet, film coated in 1 bottle72603-934-01Northstar Rx1 July 2026

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 15 April 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 Ivabradine 5 mg tablet.

Compare 1

Other strengths and forms of Ivabradine

Clinical summary

Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. MedsAcross supplies Ivabradine 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 Ivabradine

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

Data sources

Need Ivabradine 5 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.