RAPIBLYK

Product NDC
87073-110
11-digit product format
870730110
Labeler code
87073
Product ID
87073-110_4b8f0a9c-ab80-1c57-e063-6294a90a8f1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
landiolol
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
AOP Health US, LLC
Application
NDA217202
Marketing category
NDA
Marketing start
2025-05-19
Substance
LANDIOLOL HYDROCHLORIDE
Active strength
280 mg/1
Pharmacologic classes
Adrenergic beta1-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RAPIBLYK
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANDIOLOL HYDROCHLORIDE280 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG8HQ634Y17
Rxcui2712074, 2712079

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
261301f5-3e34-47e7-9f81-6774ff71833eProduct name120250724
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87073-110-01RAPIBLYK1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,16
87073-110-01RAPIBLYK1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2712074landiolol 280 MG InjectionPSN411b0949-3a5e-2a4b-e063-6394a90abcbf6
2712079Rapiblyk 280 MG InjectionPSN411b0949-3a5e-2a4b-e063-6394a90abcbf6
2712079landiolol 280 MG Injection [Rapiblyk]SBD411b0949-3a5e-2a4b-e063-6394a90abcbf6
2712074landiolol 280 MG InjectionSCD411b0949-3a5e-2a4b-e063-6394a90abcbf6
2712074landiolol 280 MG (equivalent to landiolol HCl 300 MG) InjectionSY411b0949-3a5e-2a4b-e063-6394a90abcbf6
2712079Rapiblyk 280 MG (equivalent to landiolol HCl 300 MG) InjectionSY411b0949-3a5e-2a4b-e063-6394a90abcbf6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
87073-110-01870730110011 VIAL, SINGLE-DOSE in 1 CARTON (87073-110-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2025-05-19NoNoHistorical