Prescription drug · ANDA
Sotalol Hydrochloride NDC 71205-046
Sotalol hydrochloride 80 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-046-30 | 71205004630 | 30 TABLET in 1 BOTTLE (71205-046-30)Marketed from Jun 1, 2018 | |
| 71205-046-60 | 71205004660 | 60 TABLET in 1 BOTTLE (71205-046-60)Marketed from Jun 1, 2018 | |
| 71205-046-90 | 71205004690 | 90 TABLET in 1 BOTTLE (71205-046-90)Marketed from Jun 1, 2018 |
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
- Proficient Rx LP
- 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 71205-046_8fd472ad-bdc0-4672-b67c-658ce12aafc0SPL ID 8fd472ad-bdc0-4672-b67c-658ce12aafc0SPL set ID 6acf10b5-bbd9-4993-99a9-2cdb8cec96c5RxCUI 1923426UNII HEC37C70XXUPC 0371205046309
- 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
N471205004630followed by a unit qualifier and the quantityPackage 71205-0046-30. 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 • Avoid use in patients with asymptomatic ventricular premature contraction ( 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 life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia (VT). Limitation of Use: Sotalol hydrochloride tablets may …
Excerpt only. Read the full label for complete information.
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 | Aphena Pharma Solutions - Tennessee, LLC | 71610-889 |