Prescription drug · ANDA
Sotalol Hydrochloride NDC 11788-053
Sotalol hydrochloride 160 mg/1 · Tablet · Oral · AiPing Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11788-053-01 | 11788005301 | 100 TABLET in 1 BOTTLE (11788-053-01)Marketed from Nov 1, 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)
- Sotalol Hydrochloride
- Generic name (nonproprietary)
- sotalol hydrochloride
- Active ingredients
- Sotalol hydrochloride — 160 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- AiPing Pharmaceutical, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075500
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Cardiac Rhythm Alteration (Physiologic effect)
- Identifiers
- Product ID 11788-053_d2c31b08-0c64-48be-aa84-aeaead306b2aSPL ID d2c31b08-0c64-48be-aa84-aeaead306b2aSPL set ID 56326224-fc80-4b89-8ba3-70cb873173b4RxCUI 904589, 1923422, 1923424, 1923426UNII HEC37C70XXUPC 0311788051017, 0311788052014
- 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
N411788005301followed by a unit qualifier and the quantityPackage 11788-0053-01. 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)
1. INDICATIONS AND USAGE 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075500
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 240 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2586 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2583 |
| Sotalol Hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2584 |
| Sotalol Hydrochloride | Sotalol hydrochloride 160 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2585 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | AiPing Pharmaceutical, Inc. | 11788-051 |
| Sotalol Hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | AiPing Pharmaceutical, Inc. | 11788-052 |
| Sotalol Hydrochloride | Sotalol hydrochloride 240 mg/1 | TabletOral | AiPing Pharmaceutical, Inc. | 11788-054 |