Prescription drug · ANDA
Sotalol (Sotalol hydrochloride) NDC 72162-2522
Sotalol hydrochloride 120 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2522-1 | 72162252201 | 100 TABLET in 1 BOTTLE (72162-2522-1)Marketed from Dec 15, 2017 |
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 — 120 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 72162
- 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 72162-2522_60601253-137f-4e50-9036-6f4342a544f0SPL ID 60601253-137f-4e50-9036-6f4342a544f0SPL set ID 51cebe16-4496-4f49-b2db-b7b21c08fa23RxCUI 1923422UNII 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
N472162252201followed by a unit qualifier and the quantityPackage 72162-2522-01. 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/Sotalol AF is 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 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/Sotalol AF is indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (VT). Limitation of Use: Sotalol/So…
Excerpt only. Read the full label for complete information.
About NDC 72162-2522
- What is NDC 72162-2522?
- 72162-2522 is the product NDC for Sotalol (sotalol hydrochloride), Sotalol hydrochloride 120 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sotalol (Sotalol Hydrochloride).
- What is the active ingredient?
- Sotalol hydrochloride.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 72162. 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?
- 6 other product NDCs are listed under this name. See all Sotalol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sotalol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sotalolsotalol hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1189 | 71335-1189-0171335-1189-0271335-1189-03+1 more |
| Sotalolsotalol hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2524 | 72162-2524-01 |
| Sotalolsotalol hydrochloride | Sotalol hydrochloride 80 mg/1 | TabletOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-114 | 76385-0114-0176385-0114-50 |
| Sotalolsotalol hydrochloride | Sotalol hydrochloride 160 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2523 | 72162-2523-01 |
| Sotalolsotalol hydrochloride | Sotalol hydrochloride 120 mg/1 | TabletOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-115 | 76385-0115-0176385-0115-50 |
| Sotalolsotalol hydrochloride | Sotalol hydrochloride 160 mg/1 | TabletOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-116 | 76385-0116-0176385-0116-50 |
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 | Bryant Ranch Prepack | 71335-1189 |
| 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 |
| 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 |