Betapace Af (sotalol hydrochloride) NDC 83107-008

NDC codes

FDA NDC Directory

Product NDC (as listed)83107-008Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83107-0008Add 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
83107-008-60	83107000860	60 TABLET in 1 BOTTLE (83107-008-60)Marketed from Sep 1, 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): Betapace Af
Generic name (nonproprietary): sotalol hydrochloride
Active ingredients: Sotalol hydrochloride — 80 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Legacy Pharma USA, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 019865
Marketing start: Sep 1, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)Cardiac Rhythm Alteration (Physiologic effect)
Identifiers: Product ID 83107-008_fcc2fc9c-87b2-4f9f-8d4d-b1f10214884eSPL ID fcc2fc9c-87b2-4f9f-8d4d-b1f10214884eSPL set ID a6a7702f-36c9-45db-b640-453dc324baeeRxCUI 1922720, 1922721, 1922763, 1922764, 1922765, 1922766, 1923422, 1923423, 1923424, 1923425, 1923426, 1923427UNII HEC37C70XXUPC 0383107008606, 0383107009603, 0383107006107, 0383107007104, 0383107010609, 0383107005100
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

N483107000860 followed by a unit qualifier and the quantity

Package 83107-0008-60. 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 Dec 16, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Betapace/Betapace 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 Betapace 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 Betapace/Betapace AF is indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (VT) . Limitation of Use: Betapace/Betapace AF has not …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 019865

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

FDA NDC Directory listings under NDA 019865
Product	Strength	Form · route	Labeler	Product NDC
Betapacesotalol hydrochloride	Sotalol hydrochloride 120 mg/1	TabletOral	Legacy Pharma USA, Inc.	83107-006
Betapacesotalol hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	Legacy Pharma USA, Inc.	83107-005
Betapace Afsotalol hydrochloride	Sotalol hydrochloride 160 mg/1	TabletOral	Legacy Pharma USA, Inc.	83107-010
Betapacesotalol hydrochloride	Sotalol hydrochloride 160 mg/1	TabletOral	Legacy Pharma USA, Inc.	83107-007
Betapace Afsotalol hydrochloride	Sotalol hydrochloride 120 mg/1	TabletOral	Legacy Pharma USA, Inc.	83107-009