FDA.reportPublic FDA data

Ivabradine

Product NDC
46708-679
11-digit product format
467080679
Labeler code
46708
Product ID
46708-679_51ac7345-3188-4382-ab1d-9120d6c88927
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ivabradine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA215238
Marketing category
ANDA
Marketing start
2024-12-20
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
46708-679-45Ivabradine180 in 1 BOTTLETABLET, FILM COATED1801
46708-679-60Ivabradine60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-679IVABRADINE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 2 package rows20241222_51ac7345-3188-4382-ab1d-9120d6c88927.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649485ivabradine 5 MG Oral TabletPSN51ac7345-3188-4382-ab1d-9120d6c889271
1649493ivabradine 7.5 MG Oral TabletPSN51ac7345-3188-4382-ab1d-9120d6c889271
1649485ivabradine 5 MG Oral TabletSCD51ac7345-3188-4382-ab1d-9120d6c889271
1649493ivabradine 7.5 MG Oral TabletSCD51ac7345-3188-4382-ab1d-9120d6c889271
1649485ivabradine 5 MG (as ivabradine HCl 5.39 MG) Oral TabletSY51ac7345-3188-4382-ab1d-9120d6c889271
1649493ivabradine 7.5 MG (as ivabradine HCl 8.085 MG) Oral TabletSY51ac7345-3188-4382-ab1d-9120d6c889271

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
46708-679-4546708067945180 TABLET, FILM COATED in 1 BOTTLE (46708-679-45) 2024-12-20NoNoCurrent
46708-679-604670806796060 TABLET, FILM COATED in 1 BOTTLE (46708-679-60) 2024-12-20NoNoCurrent