IVABRADINE

Product NDC
51407-592
11-digit product format
514070592
Labeler code
51407
Product ID
51407-592_32d59c63-db88-3e0c-e063-6294a90acd9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IVABRADINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA214051
Marketing category
ANDA
Marketing start
2021-12-30
Substance
IVABRADINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA], Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
TP19837BZKIVABRADINE HYDROCHLORIDE148849-67-6IVABRADINE HYDROCHLORIDE
3H48L0LPZQIVABRADINE155974-00-8IVABRADINE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51407-592-605140705926060 TABLET, FILM COATED in 1 BOTTLE (51407-592-60) 2024-08-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
IVABRADINEGolden State Medical Supply, Inc.2025-04-15HUMAN PRESCRIPTION DRUG LABEL2