Prescription drug · NDA
Sotylize (sotalol hydrochloride) NDC 24338-530
Sotalol hydrochloride 5 mg/mL · Solution · Oral · Azurity Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24338-530-25 | 24338053025 | 250 mL in 1 BOTTLE (24338-530-25)Marketed from Mar 1, 2015 | |
| 24338-530-48 | 24338053048 | 480 mL in 1 BOTTLE (24338-530-48)Marketed from Mar 1, 2015 |
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)
- Sotylize
- Generic name (nonproprietary)
- sotalol hydrochloride
- Active ingredients
- Sotalol hydrochloride — 5 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205108
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Cardiac Rhythm Alteration (Physiologic effect)
- Identifiers
- Product ID 24338-530_73961d33-7149-49f3-8386-91f1b1758ca5SPL ID 73961d33-7149-49f3-8386-91f1b1758ca5SPL set ID 1f33f900-0777-4a92-a7f7-00cf3d57d95cRxCUI 1593725, 1593731UNII HEC37C70XX
- Pharmacologic class
- Antiarrhythmic
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N424338053025followed by a unit qualifier and the quantityPackage 24338-0530-25. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
SOTYLIZE is an antiarrhythmic indicated for: The treatment of life-threatening ventricular arrhythmias ( 1.1 ) The maintenance of normal sinus rhythm in patients with highly symptomatic atrial fibrillation/flutter (AFIB/AFL) ( 1.2 ) Limitations of Use SOTYLIZE has not been shown to enhance survival in patients with life threatening ventricular arrhythmias ( 1.1 ) Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL ( 1.2 ) 1.1 Life-Threatening Ventricular Arrhythmia SOTYLIZE is indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia. Limitation of Use SOTYLIZE has not been shown to enhance surviv…
Excerpt only. Read the full label for complete information.