Prescription drug · ANDA
Sotalol (sotalol hydrochloride) NDC 71335-1189
Sotalol hydrochloride 80 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1189-1 | 71335118901 | 60 TABLET in 1 BOTTLE (71335-1189-1)Marketed from Apr 15, 2019 | |
| 71335-1189-2 | 71335118902 | 30 TABLET in 1 BOTTLE (71335-1189-2)Marketed from Apr 22, 2019 | |
| 71335-1189-3 | 71335118903 | 100 TABLET in 1 BOTTLE (71335-1189-3)Marketed from May 17, 2024 | |
| 71335-1189-4 | 71335118904 | 90 TABLET in 1 BOTTLE (71335-1189-4)Marketed from May 17, 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
- 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 207428
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Cardiac Rhythm Alteration (Physiologic effect)
- Identifiers
- Product ID 71335-1189_699df1c9-5013-44c1-a955-ab34261c14a8SPL ID 699df1c9-5013-44c1-a955-ab34261c14a8SPL set ID c824f6b2-80c5-45a6-a491-4c14c9f5e33dRxCUI 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
N471335118901followed by a unit qualifier and the quantityPackage 71335-1189-01. 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 ) Limitations of Use Avoid use in patients with asymptomatic ventricular premature contraction ( 1.1 ) 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 not enhance survival in patients with ventricular arrhythmias. Because of the proarrhythmic effects of Sotalol Hydrochloride Tablets, including a 1.5 to 2% rate of Torsade de P…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207428
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 |
|---|---|---|---|---|
| Sotalolsotalol hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-114 |
| Sotalolsotalol hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-115 |
| Sotalolsotalol hydrochloride | Sotalol hydrochloride 160 mg/1 | TabletOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-116 |
| Sotalolsotalol hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2522 |
| Sotalolsotalol hydrochloride | Sotalol hydrochloride 160 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2523 |
| Sotalolsotalol hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2524 |