What is NDC 63187-804?

63187-804 is the product NDC for Sotalol Hydrochloride, Sotalol hydrochloride 80 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 63187. 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 63187-804 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-804Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0804Add 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
63187-804-30	63187080430	30 TABLET in 1 BOTTLE (63187-804-30)Marketed from Jan 2, 2017
63187-804-60	63187080460	60 TABLET in 1 BOTTLE (63187-804-60)Marketed from Jan 2, 2017
63187-804-90	63187080490	90 TABLET in 1 BOTTLE (63187-804-90)Marketed from Jan 2, 2017

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: Proficient Rx LPNDC labeler code 63187
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076140
Marketing start: Feb 1, 2003
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)Cardiac Rhythm Alteration (Physiologic effect)
Identifiers: Product ID 63187-804_77e00163-ec11-4bba-b1f9-08313bf22310SPL ID 77e00163-ec11-4bba-b1f9-08313bf22310SPL set ID 517824b1-11be-40a9-9066-d1a6a32a2938RxCUI 1923426UNII HEC37C70XXUPC 0363187804305
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

N463187080430 followed by a unit qualifier and the quantity

Package 63187-0804-30. 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 Jul 1, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Sotalol hydrochloride tablets, USP are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. Because of the proarrhythmic effects of sotalol hydrochloride tablets, USP (see WARNINGS ), including a 1.5 to 2% rate of Torsade de Pointes or new VT/VF in patients with either NSVT or supraventricular arrhythmias, its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of sotalol hydrochloride treat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-804

What is NDC 63187-804?: 63187-804 is the product NDC for Sotalol Hydrochloride, Sotalol hydrochloride 80 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 3 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?: Proficient Rx LP, NDC labeler code 63187. 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	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	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	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 076140

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

FDA NDC Directory listings under ANDA 076140
Product	Strength	Form · route	Labeler	Product NDC
Sotalol Hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	Major Pharmaceuticals	0904-7143
Sotalol Hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	A-S Medication Solutions	50090-1299
Sotalol Hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	AvPAK	50268-724
Sotalol Hydrochloride	Sotalol hydrochloride 120 mg/1	TabletOral	AvPAK	50268-725
Sotalol Hydrochloride	Sotalol hydrochloride 240 mg/1	TabletOral	Northwind Health Company, LLC	51655-450
Sotalol Hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	Cardinal Health 107, LLC	55154-8179
Sotalol Hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	Golden State Medical Supply, Inc.	60429-748
Sotalol Hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	Apotex Corp.	60505-0080
Sotalol Hydrochloride	Sotalol hydrochloride 160 mg/1	TabletOral	Apotex Corp.	60505-0081
Sotalol Hydrochloride	Sotalol hydrochloride 240 mg/1	TabletOral	Apotex Corp.	60505-0082
Sotalol Hydrochloride	Sotalol hydrochloride 120 mg/1	TabletOral	Apotex Corp.	60505-0159
Sotalol Hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	American Health Packaging	68084-654
Sotalol Hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	Bryant Ranch Prepack	71335-0260
Sotalol Hydrochloride	Sotalol hydrochloride 120 mg/1	TabletOral	Bryant Ranch Prepack	71335-1125
Sotalol Hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-723
Sotalol Hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-849
Sotalol Hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	Bryant Ranch Prepack	72162-2118