Prescription drug · NDA
Sotalol hydrochloride NDC 69724-112
Sotalol hydrochloride 15 mg/mL · Injection · Intravenous · ALTATHERA Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69724-112-10 | 69724011210 | 1 VIAL in 1 CARTON (69724-112-10) / 10 mL in 1 VIALMarketed from Oct 15, 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)
- Sotalol hydrochloride
- Generic name (nonproprietary)
- sotalol hydrochloride
- Active ingredients
- Sotalol hydrochloride — 15 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- ALTATHERA Pharmaceuticals, LLCNDC labeler code 69724
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022306
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Cardiac Rhythm Alteration (Physiologic effect)
- Identifiers
- Product ID 69724-112_d155f318-ecbf-4392-90a1-4409c5b8d13fSPL ID d155f318-ecbf-4392-90a1-4409c5b8d13fSPL set ID ff3061ab-d930-4318-a5be-684e38be229eRxCUI 904630UNII 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 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
N469724011210followed by a unit qualifier and the quantityPackage 69724-0112-10. 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)
Sotalol is an antiarrhythmic indicated for: the treatment of life-threatening ventricular tachycardia. ( 1.1 ) the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL). ( 1.2 ) Limitations of Use Sotalol 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 Sotalol is indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia in adult and pediatric patients. Limitations of Use: Sotalol has not been shown …
Excerpt only. Read the full label for complete information.
About NDC 69724-112
- What is NDC 69724-112?
- 69724-112 is the product NDC for Sotalol hydrochloride, Sotalol hydrochloride 15 mg/mL injection, listed with the FDA by ALTATHERA Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sotalol hydrochloride.
- What is the active ingredient?
- Sotalol hydrochloride.
- Who is the labeler?
- ALTATHERA Pharmaceuticals, LLC, NDC labeler code 69724. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sotalol hydrochloride?
- 62 other product NDCs are listed under this name. See all Sotalol hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sotalol hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | AiPing Pharmaceutical, Inc. | 11788-051 | 11788-0051-01 |
| Sotalol Hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | AiPing Pharmaceutical, Inc. | 11788-052 | 11788-0052-01 |
| Sotalol Hydrochloride | Sotalol hydrochloride 160 mg/1 | TabletOral | AiPing Pharmaceutical, Inc. | 11788-053 | 11788-0053-01 |
| Sotalol Hydrochloride | Sotalol hydrochloride 240 mg/1 | TabletOral | AiPing Pharmaceutical, Inc. | 11788-054 | 11788-0054-01 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2583 | 72162-2583-01 |
| Sotalol Hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2584 | 72162-2584-01 |
| Sotalol Hydrochloride | Sotalol hydrochloride 160 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2585 | 72162-2585-01 |
| Sotalol Hydrochloride | Sotalol hydrochloride 240 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2586 | 72162-2586-01 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-775 | 59651-0775-01 |
| Sotalol Hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-776 | 59651-0776-01 |