What is NDC 71610-474?

71610-474 is the product NDC for Sotalol Hydrochloride, Sotalol hydrochloride 80 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 Hydrochloride?

62 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sotalol Hydrochloride NDC 71610-474 | National Drug Code

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 NDC	11-digit (billing)	Package	Copy
71610-474-60	71610047460	90 TABLET in 1 BOTTLE (71610-474-60)Marketed from Jan 25, 2022
71610-474-80	71610047480	180 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
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075563
Marketing start: Jul 24, 2020
Listing expires: Dec 31, 2026
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 Feb 22, 2022. 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)

About NDC 71610-474

What is NDC 71610-474?: 71610-474 is the product NDC for Sotalol Hydrochloride, Sotalol hydrochloride 80 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sotalol Hydrochloride.
What is the active ingredient?: Sotalol hydrochloride.
Who is the labeler?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 Hydrochloride?: 62 other product NDCs are listed under this name. See all Sotalol Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Sotalol Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sotalol Hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	Bryant Ranch Prepack	72162-2583	72162-2583-01
Sotalol Hydrochloride	Sotalol hydrochloride 120 mg/1	TabletOral	Bryant Ranch Prepack	72162-2584	72162-2584-01
Sotalol Hydrochloride	Sotalol hydrochloride 160 mg/1	TabletOral	Bryant Ranch Prepack	72162-2585	72162-2585-01
Sotalol Hydrochloride	Sotalol hydrochloride 240 mg/1	TabletOral	Bryant Ranch Prepack	72162-2586	72162-2586-01
Sotalol Hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	AiPing Pharmaceutical, Inc.	11788-051	11788-0051-01
Sotalol Hydrochloride	Sotalol hydrochloride 120 mg/1	TabletOral	AiPing Pharmaceutical, Inc.	11788-052	11788-0052-01
Sotalol Hydrochloride	Sotalol hydrochloride 160 mg/1	TabletOral	AiPing Pharmaceutical, Inc.	11788-053	11788-0053-01
Sotalol Hydrochloride	Sotalol hydrochloride 240 mg/1	TabletOral	AiPing Pharmaceutical, Inc.	11788-054	11788-0054-01
Sotalol Hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	Aurobindo Pharma Limited	59651-775	59651-0775-01
Sotalol Hydrochloride	Sotalol hydrochloride 120 mg/1	TabletOral	Aurobindo Pharma Limited	59651-776	59651-0776-01

All 63 Sotalol Hydrochloride NDCs

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
Product	Strength	Form · route	Labeler	Product NDC
Sotalol Hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	Bryant Ranch Prepack	71335-2823
Sotalol Hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	Oxford Pharmaceuticals, LLC	69584-841
Sotalol Hydrochloride	Sotalol hydrochloride 120 mg/1	TabletOral	Oxford Pharmaceuticals, LLC	69584-842
Sotalol Hydrochloride	Sotalol hydrochloride 160 mg/1	TabletOral	Oxford Pharmaceuticals, LLC	69584-843
Sotalol Hydrochloride	Sotalol hydrochloride 240 mg/1	TabletOral	Oxford Pharmaceuticals, LLC	69584-844
Sotalol Hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	Bryant Ranch Prepack	72162-1931
Sotalol Hydrochloride	Sotalol hydrochloride 120 mg/1	TabletOral	Bryant Ranch Prepack	72162-1932
Sotalol Hydrochloride	Sotalol hydrochloride 160 mg/1	TabletOral	Bryant Ranch Prepack	72162-1933
Sotalol Hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	Bryant Ranch Prepack	71335-1917
Sotalol Hydrochloride	Sotalol hydrochloride 160 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-135
Sotalol Hydrochloride	Sotalol hydrochloride 240 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-136
Sotalol Hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-137
Sotalol Hydrochloride	Sotalol hydrochloride 120 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-138
Sotalol Hydrochloride	Sotalol hydrochloride 160 mg/1	TabletOral	Bryant Ranch Prepack	63629-2421
Sotalol Hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	Bryant Ranch Prepack	63629-2422
Sotalol Hydrochloride	Sotalol hydrochloride 120 mg/1	TabletOral	Bryant Ranch Prepack	63629-2423
Sotalol Hydrochloride	Sotalol hydrochloride 120 mg/1	TabletOral	Proficient Rx LP	82804-951
Sotalol Hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	A-S Medication Solutions	50090-7796
Sotalol Hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	Proficient Rx LP	82804-974