Prescription drug · ANDA
Sotalol Hydrochloride NDC 71335-0260
Sotalol hydrochloride 80 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0260-1 | 71335026001 | 60 TABLET in 1 BOTTLE (71335-0260-1)Marketed from Jul 14, 2020 | |
| 71335-0260-2 | 71335026002 | 30 TABLET in 1 BOTTLE (71335-0260-2)Marketed from Jul 14, 2020 | |
| 71335-0260-3 | 71335026003 | 100 TABLET in 1 BOTTLE (71335-0260-3)Marketed from Oct 30, 2024 | |
| 71335-0260-4 | 71335026004 | 90 TABLET in 1 BOTTLE (71335-0260-4)Marketed from Oct 30, 2024 |
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 — 80 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 076140
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Cardiac Rhythm Alteration (Physiologic effect)
- Identifiers
- Product ID 71335-0260_deff5b14-286a-444c-9ee0-20722efba148SPL ID deff5b14-286a-444c-9ee0-20722efba148SPL set ID 876214ba-59c4-4acc-a8ad-c6bc91837de8RxCUI 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
N471335026001followed by a unit qualifier and the quantityPackage 71335-0260-01. 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/Sotalol hydrochloride AF 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 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/Sotalol hydrochloride AF tablets are indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustaine…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076140
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 80 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2118 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-723 |
| Sotalol Hydrochloride | Sotalol hydrochloride 240 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-450 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-8179 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-849 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | American Health Packaging | 68084-654 |
| Sotalol Hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1125 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-748 |
| Sotalol Hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | AvPAK | 50268-725 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Proficient Rx LP | 63187-804 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | AvPAK | 50268-724 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Apotex Corp. | 60505-0080 |
| Sotalol Hydrochloride | Sotalol hydrochloride 160 mg/1 | TabletOral | Apotex Corp. | 60505-0081 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | A-S Medication Solutions | 50090-1299 |
| Sotalol Hydrochloride | Sotalol hydrochloride 240 mg/1 | TabletOral | Apotex Corp. | 60505-0082 |
| Sotalol Hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7143 |
| Sotalol Hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | Apotex Corp. | 60505-0159 |