FDA.reportPublic FDA data

RAPIBLYK

Product NDC
84381-110
11-digit product format
843810110
Labeler code
84381
Product ID
84381-110_506ca7d0-9794-a2c5-e063-6394a90aeead
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
landiolol
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
AOP Orphan Pharmaceuticals GmbH
Application
NDA217202
Marketing category
NDA
Marketing start
2025-08-07
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
84381-110-01RAPIBLYK1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1106
84381-110-01RAPIBLYK1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,1106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84381-110-01EA - Each84381-11077c65bda-4868-4926-a972-d213b7be255312025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84381-110RAPIBLYK (LANDIOLOL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AOP ORPHAN PHARMACEUTICALS GMBH]4Current NDC, 2 package rows20250520_27e7f20f-78a4-f1a9-e063-6394a90ae465.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2712074landiolol 280 MG InjectionPSN27e7f20f-78a4-f1a9-e063-6394a90ae465106
2712079Rapiblyk 280 MG InjectionPSN27e7f20f-78a4-f1a9-e063-6394a90ae465106
2712079landiolol 280 MG Injection [Rapiblyk]SBD27e7f20f-78a4-f1a9-e063-6394a90ae465106
2712074landiolol 280 MG InjectionSCD27e7f20f-78a4-f1a9-e063-6394a90ae465106
2712074landiolol 280 MG (equivalent to landiolol HCl 300 MG) InjectionSY27e7f20f-78a4-f1a9-e063-6394a90ae465106
2712079Rapiblyk 280 MG (equivalent to landiolol HCl 300 MG) InjectionSY27e7f20f-78a4-f1a9-e063-6394a90ae465106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84381-110-01843810110011 VIAL, SINGLE-DOSE in 1 CARTON (84381-110-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2025-08-07NoNoHistorical