Prescription drug · ANDA

Sotalol Hydrochloride NDC 69584-843

Sotalol hydrochloride 160 mg/1 · Tablet · Oral · Oxford Pharmaceuticals, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)69584-843Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69584-0843Add 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
69584-843-1069584084310100 TABLET in 1 BOTTLE (69584-843-10)Marketed from Jul 24, 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 — 160 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Oxford Pharmaceuticals, LLCNDC labeler code 69584
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 69584-843_71c67f34-73e1-4e4c-9c72-56f4b9222a88SPL ID 71c67f34-73e1-4e4c-9c72-56f4b9222a88SPL set ID c8ac6351-b1e9-4dd2-82f2-5980814fda15RxCUI 904589, 1923422, 1923424, 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

N469584084310 followed by a unit qualifier and the quantity

Package 69584-0843-10. 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 ( 1.1 ) the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) ( 1.2 ) Limitations of Use Sotalol hydrochloride tablets have not been shown to enhance survival in patients with life-threatening ventricular arrhythmias ( 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 documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (VT) . Limita…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69584-843

What is NDC 69584-843?
69584-843 is the product NDC for Sotalol Hydrochloride, Sotalol hydrochloride 160 mg/1 tablet, listed with the FDA by Oxford Pharmaceuticals, LLC. It has 1 package NDC, 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?
Oxford Pharmaceuticals, LLC, NDC labeler code 69584. 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 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
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralProficient Rx LP82804-974

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Sotalol Hydrochloride NDC 69584-843 | National Drug Code | Med-Code