Home NDC 84381-110-01 RAPIBLYK
Product NDC 84381-110
Requested package NDC 84381-110-01
11-digit product format 843810110
Labeler code 84381
Product ID 84381-110_54d1f634-8cd7-78c6-e063-6394a90aa9fd
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217202-001 RAPIBLYK LANDIOLOL HYDROCHLORIDE EQ 280MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-11-22
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217202-001 10722516 2034-04-25 U-4235 2025-08-14
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217202-001 NPP 2029-02-13 N217202-001 NCE 2029-11-22
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N217202-001 RAPIBLYK EQ 280MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-11-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217202-001 RAPIBLYK EQ 280MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-11-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217202-001 RAPIBLYK EQ 280MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-11-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217202-001 RAPIBLYK EQ 280MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-11-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217202-001 RAPIBLYK EQ 280MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-11-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217202-001 RAPIBLYK EQ 280MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-11-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217202-001 RAPIBLYK EQ 280MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-11-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217202-001 RAPIBLYK EQ 280MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-11-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217202-001 RAPIBLYK EQ 280MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-11-22 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217202-001 RAPIBLYK EQ 280MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-11-22 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N217202-001 10722516 2034-04-25 U-4235 2025-08-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217202-001 10722516 2034-04-25 U-4235 2025-08-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217202-001 10722516 2034-04-25 U-4235 2025-08-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217202-001 10722516 2034-04-25 U-4235 2025-08-14 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217202-001 10722516 2034-04-25 U-4235 2025-08-14 a50c72e98297…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base RAPIBLYK
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LANDIOLOL HYDROCHLORIDE 280 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G8HQ634Y17 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2712074 Internal RxNorm lookup 2712079 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84381-110-01 RAPIBLYK 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 106 84381-110-01 RAPIBLYK 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 106
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84381-110 RAPIBLYK (LANDIOLOL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AOP ORPHAN PHARMACEUTICALS GMBH] 4 Current NDC, 2 package rows 20250520_27e7f20f-78a4-f1a9-e063-6394a90ae465.zip
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 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 84381-110-01 84381011001 1 VIAL, SINGLE-DOSE in 1 CARTON (84381-110-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2025-08-07 No No Current