FDA.reportPublic FDA data

ivabradine

Product NDC
70710-1471
11-digit product format
707101471
Labeler code
70710
Product ID
70710-1471_cbea8583-e207-402a-b79a-83ff14a3fa9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ivabradine
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
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
70710-1471-6ivabradine60 in 1 BOTTLETABLET601
70710-1471-8ivabradine180 in 1 BOTTLETABLET1801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1471IVABRADINE TABLET [ZYDUS PHARMACEUTICALS USA INC.]1Current NDC, 2 package rows20240702_89134202-971b-4413-a9c9-d31a5c29722b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649485ivabradine 5 MG Oral TabletPSN89134202-971b-4413-a9c9-d31a5c29722b1
1649493ivabradine 7.5 MG Oral TabletPSN89134202-971b-4413-a9c9-d31a5c29722b1
1649485ivabradine 5 MG Oral TabletSCD89134202-971b-4413-a9c9-d31a5c29722b1
1649493ivabradine 7.5 MG Oral TabletSCD89134202-971b-4413-a9c9-d31a5c29722b1
1649485ivabradine 5 MG (as ivabradine HCl 5.39 MG) Oral TabletSY89134202-971b-4413-a9c9-d31a5c29722b1
1649493ivabradine 7.5 MG (as ivabradine HCl 8.085 MG) Oral TabletSY89134202-971b-4413-a9c9-d31a5c29722b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-1471-67071014710660 TABLET in 1 BOTTLE (70710-1471-6) 60 tablet2024-07-02NoNoCurrent
70710-1471-870710147108180 TABLET in 1 BOTTLE (70710-1471-8) 180 tablet2024-07-02NoNoCurrent