NDC 55513-813

Corlanor

Ivabradine

Corlanor is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Amgen Inc. The primary component is Ivabradine Hydrochloride.

Product ID55513-813_17727cc4-117c-47b3-bf1d-bbc2968c51b6
NDC55513-813
Product TypeHuman Prescription Drug
Proprietary NameCorlanor
Generic NameIvabradine
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2019-04-19
Marketing CategoryNDA / NDA
Application NumberNDA209964
Labeler NameAmgen Inc
Substance NameIVABRADINE HYDROCHLORIDE
Active Ingredient Strength5 mg/5mL
Pharm ClassesHyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC],Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55513-813-28

28 AMPULE in 1 CARTON (55513-813-28) > 5 mL in 1 AMPULE (55513-813-01)
Marketing Start Date2019-04-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55513-813-28 [55513081328]

Corlanor SOLUTION
Marketing CategoryNDA
Application NumberNDA209964
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-04-19

NDC 55513-813-01 [55513081301]

Corlanor SOLUTION
Marketing CategoryNDA
Application NumberNDA209964
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-04-19

Drug Details

NDC Crossover Matching brand name "Corlanor" or generic name "Ivabradine"

NDCBrand NameGeneric Name
55513-800Corlanorivabradine
55513-810Corlanorivabradine
55513-813Corlanorivabradine
70518-3309Corlanorivabradine

Trademark Results [Corlanor]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CORLANOR
CORLANOR
79157808 4834147 Live/Registered
BIOFARMA
2014-10-03
CORLANOR
CORLANOR
77684533 3751418 Live/Registered
BIOFARMA
2009-03-05

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