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IVABRADINE HYDROCHLORIDE

ANDA

IVABRADINE HYDROCHLORIDE | A215238 | ALEMBIC PHARMACEUTICALS LTD

2 strengths0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 2 NDCs

Highest NADAC/Unit

$0.7645

per ea

Lowest NADAC/Unit

$0.6606

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
62332067960IVABRADINE HCL 5 MG TABLET	$0.7645	EA	Generic	—	2026-08-19
62332068060IVABRADINE HCL 7.5 MG TABLET	$0.6606	EA	Generic	—	2026-08-19

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain10 active DMFs

10 active API suppliers hold Drug Master Files for this ingredient.

ORIL INDUSTRIEIVABRADINE HYDROCHLORIDE

DMF 279792014

BEIJING HUIKANG BOYUAN CHEMICAL TECH CO LTDIVABRADINE HYDROCHLORIDE

DMF 286582014

ALEMBIC PHARMACEUTICALS LTDIVABRADINE HYDROCHLORIDE

DMF 320742017

ZHEJIANG LIAOYUAN PHARMACEUTICAL CO LTDIVABRADINE HYDROCHLORIDE

DMF 326162019

BIONPHARMA INCIVABRADINE HYDROCHLORIDE

DMF 330772018

ZYDUS LIFESCIENCES LTDIVABRADINE HYDROCHLORIDE

DMF 331072018

URQUIMA SAIVABRADINE HYDROCHLORIDE (FORM IV)

DMF 332132018

MAITHRI LABORATORIES PRIVATE LTDIVABRADINE HYDROCHLORIDE

DMF 332462018

HETERO DRUGS LTDIVABRADINE HYDROCHLORIDE

DMF 333682018

FUXIN LONG RUI PHARMACEUTICAL CO LTDIVABRADINE HYDROCHLORIDE

DMF 333772018

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 26, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 5MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 8, 2024

No patent or exclusivity listings for this strength.

#002 — EQ 7.5MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 8, 2024