Sotalol hydrochloride NDC 42806-121

NDC codes

FDA NDC Directory

Product NDC (as listed)42806-121Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42806-0121Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
42806-121-01	42806012101	100 TABLET in 1 BOTTLE (42806-121-01)Marketed from Jan 4, 2016
42806-121-10	42806012110	1000 TABLET in 1 BOTTLE (42806-121-10)Marketed from Jan 4, 2016

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: Epic Pharma, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077070
Marketing start: Jan 4, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)Cardiac Rhythm Alteration (Physiologic effect)
Identifiers: Product ID 42806-121_34ed0846-81bd-46c4-a57c-b617c7d8232dSPL ID 34ed0846-81bd-46c4-a57c-b617c7d8232dSPL set ID c0a34c56-9641-4592-9754-bcc233ec86b6RxCUI 1922720, 1922763, 1922765UNII HEC37C70XXUPC 0342806121016, 0342806122013
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

N442806012101 followed by a unit qualifier and the quantity

Package 42806-0121-01. 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 Jun 4, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Sotalol hydrochloride tablets (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 hydrochloride tablets (AF) 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 tablets (AF) are indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tach…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077070

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 077070
Product	Strength	Form · route	Labeler	Product NDC
Sotalol hydrochloride	Sotalol hydrochloride 120 mg/1	TabletOral	Epic Pharma, LLC	42806-122
Sotalol hydrochloride	Sotalol hydrochloride 160 mg/1	TabletOral	Epic Pharma, LLC	42806-123