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 2 of 157 · 3,128 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
IvabradineIVABRADINENovadoz Pharmaceuticals LLC676907d3-b374-4baa-8422-c047064095402026-08-20Warnings, Adverse reactionsExact identifier
rxcui: 1649493
rxcui: 1649485
unii: TP19837BZK
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
unii: 3NXW29V3WO
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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