FDA.reportPublic FDA data

NDC 55513-813-01 - Corlanor

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
55513-813
Requested NDC
55513-813-01
Package NDCs from labels
55513-813-01, 55513-813-28
Manufacturer
Amgen Inc
Effective date
2025-11-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Corlanor - Amgen IncAmgen Inc2025-11-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55513-813-01Corlanor5 mL in 1 AMPULESOLUTION533
55513-813-28Corlanor28 in 1 CARTONSOLUTION2833

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-813CORLANOR (IVABRADINE) TABLET, FILM COATED CORLANOR (IVABRADINE) SOLUTION [AMGEN INC]31Current NDC, Legacy NDC, 2 package rows20230615_92018a65-38f6-45f7-91d4-a34921b81d0d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-813-01ML - Milliliter55513-813d0566713-5f02-441a-8042-b3b57ee58b8f12019-09-05
55513-813-28ML - Milliliter55513-81376d80b3c-6146-4d32-9122-f58f17b8499712019-09-05

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 7 of 154 · 3,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREENTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.54fc80b7-8f6c-e2be-e063-6394a90a4b592026-06-24WarningsExact identifier
unii: 15FIX9V2JP
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc54ecaea7-dafe-9694-e063-6394a90ae3b52026-06-23WarningsExact identifier
unii: 15FIX9V2JP
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
unii: 15FIX9V2JP
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
unii: 15FIX9V2JP
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
unii: 15FIX9V2JP
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc548b7c90-ef97-38ab-e063-6394a90ac6092026-06-18WarningsExact identifier
unii: 15FIX9V2JP
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlowBiotics Tinted Sunscreen SPF 30ZINC OXIDERum Brands, LLC544dba29-4785-4ab6-e063-6394a90a17b32026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe Prime and DefendZINC OXIDE SUNSCREENSociete Clinical Skincare5439bd31-5ee1-9bca-e063-6394a90a748c2026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe CoverShield Tinted SPFZINC OXIDESociete Clinical Skincare545efbc4-82d4-f126-e063-6294a90a97102026-06-16WarningsExact identifier
unii: 15FIX9V2JP
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC546347e5-841e-15ca-e063-6294a90a0c8b2026-06-16WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC5463f869-2b92-4551-e063-6394a90ad6f92026-06-16WarningsExact identifier
unii: PDC6A3C0OX
H-Scars FormulaCALENDULA OFFICINALLIS, SILICEAHealing Natural Oils LLC8433ff00-d815-45e0-b0ec-1448668dd8f82026-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
MINICA-SGLYCERINSato Pharmaceutical Co., Ltd.687902eb-e702-4e87-a0ce-9add05e3cbc12026-06-16WarningsExact identifier
unii: PDC6A3C0OX
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
Shield by HEALTHY SKIN LAB MD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED6838b754-9915-48ff-af35-5338dbd06ac42026-06-15WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.