Prescription drug · NDA
Rapiblyk (Landiolol) NDC 84381-110
Landiolol hydrochloride 280 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous · AOP Orphan Pharmaceuticals GmbH
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84381-110-01 | 84381011001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (84381-110-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSEMarketed from Aug 7, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Rapiblyk
- Generic name (nonproprietary)
- landiolol
- Active ingredients
- Landiolol hydrochloride — 280 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- AOP Orphan Pharmaceuticals GmbHNDC labeler code 84381
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217202
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta1-Antagonists (Mechanism)
- Identifiers
- Product ID 84381-110_54d1f634-8cd7-78c6-e063-6394a90aa9fdSPL ID 54d1f634-8cd7-78c6-e063-6394a90aa9fdSPL set ID 27e7f20f-78a4-f1a9-e063-6394a90ae465RxCUI 2712074, 2712079UNII G8HQ634Y17UPC 0384381110016
- Pharmacologic class
- beta-Adrenergic Blocker
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N484381011001followed by a unit qualifier and the quantityPackage 84381-0110-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
RAPIBLYK is indicated for the short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter, and pediatric patients with supraventricular tachycardia. RAPIBLYK is a beta adrenergic blocker indicated for the short-term reduction of ventricular rate in: adults with supraventricular tachycardia including atrial fibrillation and atrial flutter ( 1 ), and pediatric patients with supraventricular tachycardia.( 1 )
Excerpt only. Read the full label for complete information.
About NDC 84381-110
- What is NDC 84381-110?
- 84381-110 is the product NDC for Rapiblyk (landiolol), Landiolol hydrochloride 280 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by AOP Orphan Pharmaceuticals GmbH. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rapiblyk (Landiolol).
- What is the active ingredient?
- Landiolol hydrochloride.
- Who is the labeler?
- AOP Orphan Pharmaceuticals GmbH, NDC labeler code 84381. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rapiblyk?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.