Prescription drug · ANDA

Sotalol Hydrochloride NDC 82804-974

Sotalol hydrochloride 80 mg/1 · Tablet · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)82804-974Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82804-0974Add 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
82804-974-0082804097400100 TABLET in 1 BOTTLE (82804-974-00)Marketed from Feb 13, 2025
82804-974-11828040974111000 TABLET in 1 BOTTLE (82804-974-11)Marketed from Feb 13, 2025
82804-974-308280409743030 TABLET in 1 BOTTLE (82804-974-30)Marketed from Feb 13, 2025
82804-974-5582804097455500 TABLET in 1 BOTTLE (82804-974-55)Marketed from Feb 13, 2025
82804-974-608280409746060 TABLET in 1 BOTTLE (82804-974-60)Marketed from Feb 13, 2025
82804-974-7282804097472120 TABLET in 1 BOTTLE (82804-974-72)Marketed from Feb 13, 2025
82804-974-908280409749090 TABLET in 1 BOTTLE (82804-974-90)Marketed from Feb 13, 2025

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 82804
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 82804-974_959dc952-bed6-4538-a1a6-61ed10c06be4SPL ID 959dc952-bed6-4538-a1a6-61ed10c06be4SPL set ID b534c632-3b67-4812-a045-3e582eda6de4RxCUI 1923426UNII HEC37C70XXUPC 0382804974306
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

N482804097400 followed by a unit qualifier and the quantity

Package 82804-0974-00. 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 tablets are an antiarrhythmic indicated for: • the treatment of life-threatening ventricular arrhythmias ( Error! Hyperlink reference not valid. ) • the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) ( Error! Hyperlink reference not valid. ) Limitations of Use • Sotalol hydrochloride tablets have not been shown to enhance survival in patients with life-threatening ventricular arrhythmias ( Error! Hyperlink reference not valid. ) • Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL ( Error! Hyperlink reference not valid. ) 1.1 Life-Threatening Ventricular Arrhythmias Sotalol hydrochloride tablets …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82804-974

What is NDC 82804-974?
82804-974 is the product NDC for Sotalol Hydrochloride, Sotalol hydrochloride 80 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 7 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 82804. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralBryant Ranch Prepack72162-258372162-2583-01
Sotalol HydrochlorideSotalol hydrochloride 120 mg/1TabletOralBryant Ranch Prepack72162-258472162-2584-01
Sotalol HydrochlorideSotalol hydrochloride 160 mg/1TabletOralBryant Ranch Prepack72162-258572162-2585-01
Sotalol HydrochlorideSotalol hydrochloride 240 mg/1TabletOralBryant Ranch Prepack72162-258672162-2586-01
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralAiPing Pharmaceutical, Inc.11788-05111788-0051-01
Sotalol HydrochlorideSotalol hydrochloride 120 mg/1TabletOralAiPing Pharmaceutical, Inc.11788-05211788-0052-01
Sotalol HydrochlorideSotalol hydrochloride 160 mg/1TabletOralAiPing Pharmaceutical, Inc.11788-05311788-0053-01
Sotalol HydrochlorideSotalol hydrochloride 240 mg/1TabletOralAiPing Pharmaceutical, Inc.11788-05411788-0054-01
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralAurobindo Pharma Limited59651-77559651-0775-01
Sotalol HydrochlorideSotalol hydrochloride 120 mg/1TabletOralAurobindo Pharma Limited59651-77659651-0776-01

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
ProductStrengthForm · routeLabelerProduct NDC
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralBryant Ranch Prepack71335-2823
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-474
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralOxford Pharmaceuticals, LLC69584-841
Sotalol HydrochlorideSotalol hydrochloride 120 mg/1TabletOralOxford Pharmaceuticals, LLC69584-842
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 160 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-135
Sotalol HydrochlorideSotalol hydrochloride 240 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-136
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-137
Sotalol HydrochlorideSotalol hydrochloride 120 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-138
Sotalol HydrochlorideSotalol hydrochloride 160 mg/1TabletOralBryant Ranch Prepack63629-2421
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralBryant Ranch Prepack63629-2422
Sotalol HydrochlorideSotalol hydrochloride 120 mg/1TabletOralBryant Ranch Prepack63629-2423
Sotalol HydrochlorideSotalol hydrochloride 120 mg/1TabletOralProficient Rx LP82804-951
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralA-S Medication Solutions50090-7796

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