FDA.reportPublic FDA data

ivabradine

Product NDC
70771-1863
11-digit product format
707711863
Labeler code
70771
Product ID
70771-1863_b83cc3b5-db55-4fc0-a89d-2cae17fcd445
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ivabradine
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA213442
Marketing category
ANDA
Marketing start
2024-07-02
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

Additional Listing Data#

Finished product
Yes
Brand name base
ivabradine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IVABRADINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTP19837BZK
Rxcui1649485, 1649493

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
eebd3ed3-f483-47f1-9e64-83ee4010ac6eProduct name520260130

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1863-6ivabradine60 in 1 BOTTLETABLET602
70771-1863-8ivabradine180 in 1 BOTTLETABLET1802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1863IVABRADINE TABLET [ZYDUS LIFESCIENCES LIMITED]2Current NDC, 2 package rows20241204_246b495a-ea7b-4cbe-9a5f-87c2c0a59cb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649485ivabradine 5 MG Oral TabletPSN246b495a-ea7b-4cbe-9a5f-87c2c0a59cb32
1649493ivabradine 7.5 MG Oral TabletPSN246b495a-ea7b-4cbe-9a5f-87c2c0a59cb32
1649485ivabradine 5 MG Oral TabletSCD246b495a-ea7b-4cbe-9a5f-87c2c0a59cb32
1649493ivabradine 7.5 MG Oral TabletSCD246b495a-ea7b-4cbe-9a5f-87c2c0a59cb32
1649485ivabradine 5 MG (as ivabradine HCl 5.39 MG) Oral TabletSY246b495a-ea7b-4cbe-9a5f-87c2c0a59cb32
1649493ivabradine 7.5 MG (as ivabradine HCl 8.085 MG) Oral TabletSY246b495a-ea7b-4cbe-9a5f-87c2c0a59cb32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1863-67077118630660 TABLET in 1 BOTTLE (70771-1863-6) 60 tablet2024-07-02NoNoHistorical
70771-1863-870771186308180 TABLET in 1 BOTTLE (70771-1863-8) 180 tablet2024-07-02NoNoHistorical