FDA.reportPublic FDA data

Corlanor

Product NDC
55513-800
11-digit product format
555130800
Labeler code
55513
Product ID
55513-800_8ab000cd-0258-489a-b1bb-4cc1ca359d6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ivabradine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amgen Inc
Application
NDA206143
Marketing category
NDA
Marketing start
2015-04-20
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
Corlanor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IVABRADINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTP19837BZK
Rxcui1649485, 1649491, 1649493, 1649495, 2168592, 2168596

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
55513-800-60Corlanor60 in 1 BOTTLETABLET, FILM COATED6033
55513-800-99Corlanor14 in 1 BOTTLETABLET, FILM COATED1433

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-800-60EA - Each55513-8009bb3fbb7-74d4-4981-a26d-2f487db740f412015-06-09
55513-800-80EA - Each55513-8005101b3fe-a95e-401e-9227-cf6c91c5781712015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IVABRADINE HYDROCHLORIDEACTIVE INGREDIENTTP19837BZKCORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]4
IVABRADINEACTIVE MOIETY3H48L0LPZQCORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]4
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DCORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]4
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WECORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCORLANOR (IVABRADINE HYDROCHLORIDE) TABLET, FILM COATED [AMGEN INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-800CORLANOR (IVABRADINE) TABLET, FILM COATED CORLANOR (IVABRADINE) SOLUTION [AMGEN INC]31Current NDC, Legacy NDC, 2 package rows20230615_92018a65-38f6-45f7-91d4-a34921b81d0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2168596Corlanor 5 MG in 5 mL Oral SolutionPSN92018a65-38f6-45f7-91d4-a34921b81d0d33
1649491Corlanor 5 MG Oral TabletPSN92018a65-38f6-45f7-91d4-a34921b81d0d33
1649495Corlanor 7.5 MG Oral TabletPSN92018a65-38f6-45f7-91d4-a34921b81d0d33
2168592ivabradine 5 MG in 5 mL Oral SolutionPSN92018a65-38f6-45f7-91d4-a34921b81d0d33
1649485ivabradine 5 MG Oral TabletPSN92018a65-38f6-45f7-91d4-a34921b81d0d33
1649493ivabradine 7.5 MG Oral TabletPSN92018a65-38f6-45f7-91d4-a34921b81d0d33
2168596ivabradine 1 MG/ML Oral Solution [Corlanor]SBD92018a65-38f6-45f7-91d4-a34921b81d0d33
1649491ivabradine 5 MG Oral Tablet [Corlanor]SBD92018a65-38f6-45f7-91d4-a34921b81d0d33
1649495ivabradine 7.5 MG Oral Tablet [Corlanor]SBD92018a65-38f6-45f7-91d4-a34921b81d0d33
2168592ivabradine 1 MG/ML Oral SolutionSCD92018a65-38f6-45f7-91d4-a34921b81d0d33
1649485ivabradine 5 MG Oral TabletSCD92018a65-38f6-45f7-91d4-a34921b81d0d33
1649493ivabradine 7.5 MG Oral TabletSCD92018a65-38f6-45f7-91d4-a34921b81d0d33
2168596Corlanor 1 MG/ML Oral SolutionSY92018a65-38f6-45f7-91d4-a34921b81d0d33
1649491Corlanor 5 MG (as ivabradine HCl 5.39 MG) Oral TabletSY92018a65-38f6-45f7-91d4-a34921b81d0d33
2168596Corlanor 5 MG per 5 ML (as ivabradine HCl 5.39 MG) Oral SolutionSY92018a65-38f6-45f7-91d4-a34921b81d0d33
1649495Corlanor 7.5 MG (as ivabradine HCl 8.085 MG) Oral TabletSY92018a65-38f6-45f7-91d4-a34921b81d0d33
1649485ivabradine 5 MG (as ivabradine HCl 5.39 MG) Oral TabletSY92018a65-38f6-45f7-91d4-a34921b81d0d33
2168592ivabradine 5 MG per 5 ML (as ivabradine HCl 5.39 MG) Oral SolutionSY92018a65-38f6-45f7-91d4-a34921b81d0d33
1649493ivabradine 7.5 MG (as ivabradine HCl 8.085 MG) Oral TabletSY92018a65-38f6-45f7-91d4-a34921b81d0d33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55513-800-605551308006060 TABLET, FILM COATED in 1 BOTTLE (55513-800-60) 2015-04-200000-00-00NoNoCurrent
55513-800-8055513080080180 TABLET, FILM COATED in 1 BOTTLE (55513-800-80) 2015-04-200000-00-00NoNoCurrent
55513-800-995551308009914 TABLET, FILM COATED in 1 BOTTLE (55513-800-99) 2015-04-200000-00-00YesNoCurrent