What is NDC 71205-046?

71205-046 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 71205. 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 71205-046 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71205-046Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71205-0046Add 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
71205-046-30	71205004630	30 TABLET in 1 BOTTLE (71205-046-30)Marketed from Jun 1, 2018
71205-046-60	71205004660	60 TABLET in 1 BOTTLE (71205-046-60)Marketed from Jun 1, 2018
71205-046-90	71205004690	90 TABLET in 1 BOTTLE (71205-046-90)Marketed from Jun 1, 2018

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 71205
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075429
Marketing start: May 4, 2000
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)Cardiac Rhythm Alteration (Physiologic effect)
Identifiers: Product ID 71205-046_8fd472ad-bdc0-4672-b67c-658ce12aafc0SPL ID 8fd472ad-bdc0-4672-b67c-658ce12aafc0SPL set ID 6acf10b5-bbd9-4993-99a9-2cdb8cec96c5RxCUI 1923426UNII HEC37C70XXUPC 0371205046309
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

N471205004630 followed by a unit qualifier and the quantity

Package 71205-0046-30. 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 Oct 1, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Sotalol hydrochloride tablets are 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 hydrochloride tablets are indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia (VT). Limitation of Use: Sotalol hydrochloride tablets may …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71205-046

What is NDC 71205-046?: 71205-046 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 71205. 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 120 mg/1	TabletOral	Bryant Ranch Prepack	72162-2584	72162-2584-01
Sotalol Hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	Bryant Ranch Prepack	72162-2583	72162-2583-01
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 240 mg/1	TabletOral	AiPing Pharmaceutical, Inc.	11788-054	11788-0054-01
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 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 075429

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

FDA NDC Directory listings under ANDA 075429
Product	Strength	Form · route	Labeler	Product NDC
Sotalol Hydrochloride	Sotalol hydrochloride 120 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	0093-1060
Sotalol Hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	0093-1061
Sotalol Hydrochloride	Sotalol hydrochloride 160 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	0093-1062
Sotalol Hydrochloride	Sotalol hydrochloride 240 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	0093-1063
Sotalol Hydrochloride	Sotalol hydrochloride 80 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-889