Prescription drug · ANDA
Sotalol Hydrochloride NDC 63629-2421
Sotalol hydrochloride 160 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2421-1 | 63629242101 | 100 TABLET in 1 BOTTLE (63629-2421-1)Marketed from Jun 24, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 160 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075563
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Cardiac Rhythm Alteration (Physiologic effect)
- Identifiers
- Product ID 63629-2421_c5599033-9596-4bc3-adb9-d2131d8aad60SPL ID c5599033-9596-4bc3-adb9-d2131d8aad60SPL set ID f8d0daf3-5eab-44f1-9dec-40e5d9c2bbcfRxCUI 1923424UNII 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
N463629242101followed by a unit qualifier and the quantityPackage 63629-2421-01. 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 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 have 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 are indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (VT) . Limita…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075563
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 | Proficient Rx LP | 82804-951 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2823 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Proficient Rx LP | 82804-974 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-474 |
| Sotalol Hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | Oxford Pharmaceuticals, LLC | 69584-842 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Oxford Pharmaceuticals, LLC | 69584-841 |
| Sotalol Hydrochloride | Sotalol hydrochloride 160 mg/1 | TabletOral | Oxford Pharmaceuticals, LLC | 69584-843 |
| Sotalol Hydrochloride | Sotalol hydrochloride 240 mg/1 | TabletOral | Oxford Pharmaceuticals, LLC | 69584-844 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1931 |
| Sotalol Hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1932 |
| Sotalol Hydrochloride | Sotalol hydrochloride 160 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1933 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1917 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-137 |
| Sotalol Hydrochloride | Sotalol hydrochloride 160 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-135 |
| Sotalol Hydrochloride | Sotalol hydrochloride 240 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-136 |
| Sotalol Hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-138 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2422 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | A-S Medication Solutions | 50090-7796 |
| Sotalol Hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2423 |