Prescription drug · ANDA

Sotalol Hydrochloride NDC 71610-474

Sotalol hydrochloride 80 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)71610-474Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71610-0474Add 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 NDC11-digit (billing)PackageCopy
71610-474-607161004746090 TABLET in 1 BOTTLE (71610-474-60)Marketed from Jan 25, 2022
71610-474-8071610047480180 TABLET in 1 BOTTLE (71610-474-80)Marketed from Oct 15, 2020

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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075563
Marketing start
Listing expires
Other FDA classes
Adrenergic beta-Antagonists (Mechanism)Cardiac Rhythm Alteration (Physiologic effect)
Identifiers
Product ID 71610-474_c2c1a3a6-f70e-4b47-85b6-e4d10c110588SPL ID c2c1a3a6-f70e-4b47-85b6-e4d10c110588SPL set ID 253da1e1-022a-4175-bd7f-e7673cba0767RxCUI 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

N471610047460 followed by a unit qualifier and the quantity

Package 71610-0474-60. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Sotalol hydrochloride 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 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 is indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia (VT) . Limitation of Use: Sotalol may not enhance survival in patients with ventricular arrhythmias…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075563

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

FDA NDC Directory listings under ANDA 075563
ProductStrengthForm · routeLabelerProduct NDC
Sotalol HydrochlorideSotalol hydrochloride 120 mg/1TabletOralProficient Rx LP82804-951
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralBryant Ranch Prepack71335-2823
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralProficient Rx LP82804-974
Sotalol HydrochlorideSotalol hydrochloride 120 mg/1TabletOralOxford Pharmaceuticals, LLC69584-842
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralOxford Pharmaceuticals, LLC69584-841
Sotalol HydrochlorideSotalol hydrochloride 160 mg/1TabletOralOxford Pharmaceuticals, LLC69584-843
Sotalol HydrochlorideSotalol hydrochloride 240 mg/1TabletOralOxford Pharmaceuticals, LLC69584-844
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralBryant Ranch Prepack72162-1931
Sotalol HydrochlorideSotalol hydrochloride 120 mg/1TabletOralBryant Ranch Prepack72162-1932
Sotalol HydrochlorideSotalol hydrochloride 160 mg/1TabletOralBryant Ranch Prepack72162-1933
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralBryant Ranch Prepack71335-1917
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-137
Sotalol HydrochlorideSotalol hydrochloride 160 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-135
Sotalol HydrochlorideSotalol hydrochloride 240 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-136
Sotalol HydrochlorideSotalol hydrochloride 120 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-138
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralBryant Ranch Prepack63629-2422
Sotalol HydrochlorideSotalol hydrochloride 160 mg/1TabletOralBryant Ranch Prepack63629-2421
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralA-S Medication Solutions50090-7796
Sotalol HydrochlorideSotalol hydrochloride 120 mg/1TabletOralBryant Ranch Prepack63629-2423

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