Prescription drug · ANDA
Sotalol Hydrochloride NDC 59651-775
Sotalol hydrochloride 80 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-775-01 | 59651077501 | 100 TABLET in 1 BOTTLE (59651-775-01)Marketed from Jun 29, 2023 |
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 — 80 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077616
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Cardiac Rhythm Alteration (Physiologic effect)
- Identifiers
- Product ID 59651-775_8a142042-e510-4232-8f20-5c92a991bd91SPL ID 8a142042-e510-4232-8f20-5c92a991bd91SPL set ID 6f3145d7-f3c9-4456-a77d-d04c54f24668RxCUI 1922720, 1922763, 1922765UNII 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
N459651077501followed by a unit qualifier and the quantityPackage 59651-0775-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Sotalol hydrochloride tablets (AF) are an antiarrhythmic indicated for: the treatment of life-threatening ventricular arrhythmias ( 1.1 ) the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) ( 1.2 ) Limitations of Use Sotalol hydrochloride tablets (AF) 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 Arrhythmias Sotalol hydrochloride tablets (AF) are indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia…
Excerpt only. Read the full label for complete information.
About NDC 59651-775
- What is NDC 59651-775?
- 59651-775 is the product NDC for Sotalol Hydrochloride, Sotalol hydrochloride 80 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. 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?
- Aurobindo Pharma Limited, NDC labeler code 59651. 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 120 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2584 | 72162-2584-01 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2583 | 72162-2583-01 |
| 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 240 mg/1 | TabletOral | AiPing Pharmaceutical, Inc. | 11788-054 | 11788-0054-01 |
| 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 120 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-776 | 59651-0776-01 |
| Sotalol Hydrochloride | Sotalol hydrochloride 160 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-777 | 59651-0777-01 |
Other NDCs under ANDA 077616
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Sotalol Hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-776 |
| Sotalol Hydrochloride | Sotalol hydrochloride 160 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-777 |