Prescription drug · ANDA
Sotalol Hydrochloride NDC 71610-889
Sotalol hydrochloride 80 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-889-80 | 71610088980 | 180 TABLET in 1 BOTTLE (71610-889-80)Marketed from Mar 21, 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 — 80 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075429
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Cardiac Rhythm Alteration (Physiologic effect)
- Identifiers
- Product ID 71610-889_314047e7-4b8f-27ac-e063-6294a90a2b83SPL ID 314047e7-4b8f-27ac-e063-6294a90a2b83SPL set ID 31404462-7fa0-20d6-e063-6294a90aa58cRxCUI 1923426UNII 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
N471610088980followed by a unit qualifier and the quantityPackage 71610-0889-80. 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). Limitat…
Excerpt only. Read the full label for complete information.
About NDC 71610-889
- What is NDC 71610-889?
- 71610-889 is the product NDC for Sotalol Hydrochloride, Sotalol hydrochloride 80 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, 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?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 |
Other NDCs under ANDA 075429
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 | Teva Pharmaceuticals USA, Inc. | 0093-1060 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-1061 |
| Sotalol Hydrochloride | Sotalol hydrochloride 160 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-1062 |
| Sotalol Hydrochloride | Sotalol hydrochloride 240 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-1063 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Proficient Rx LP | 71205-046 |