NDC codes

FDA NDC Directory
Product NDC (as listed)55154-8179Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55154-8179Add 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
55154-8179-05515481790010 BLISTER PACK in 1 BAG (55154-8179-0) / 1 TABLET in 1 BLISTER PACKMarketed from Mar 11, 2014

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Cardinal Health 107, LLCNDC labeler code 55154
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076140
Marketing start
Listing expires
Other FDA classes
Adrenergic beta-Antagonists (Mechanism)Cardiac Rhythm Alteration (Physiologic effect)
Identifiers
Product ID 55154-8179_860b7d5f-efce-45a9-91d9-273d318ed5c3SPL ID 860b7d5f-efce-45a9-91d9-273d318ed5c3SPL set ID 4f5902e1-9f9f-4c6b-817d-2efbb5e28061RxCUI 1923426UNII HEC37C70XXUPC 0055154817905
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

N455154817900 followed by a unit qualifier and the quantity

Package 55154-8179-00. 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/Sotalol hydrochloride AF 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 has 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/Sotalol hydrochloride AF tablets are indicated for the treatment of documented, life-threatening, ventricular arrhythmias, such as susta…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55154-8179

What is NDC 55154-8179?
55154-8179 is the product NDC for Sotalol Hydrochloride, Sotalol hydrochloride 80 mg/1 tablet, listed with the FDA by Cardinal Health 107, 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?
Cardinal Health 107, LLC, NDC labeler code 55154. 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/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/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/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 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
ProductStrengthForm · routeLabelerProduct NDC
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralMajor Pharmaceuticals0904-7143
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralA-S Medication Solutions50090-1299
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralAvPAK50268-724
Sotalol HydrochlorideSotalol hydrochloride 120 mg/1TabletOralAvPAK50268-725
Sotalol HydrochlorideSotalol hydrochloride 240 mg/1TabletOralNorthwind Health Company, LLC51655-450
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralGolden State Medical Supply, Inc.60429-748
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralApotex Corp.60505-0080
Sotalol HydrochlorideSotalol hydrochloride 160 mg/1TabletOralApotex Corp.60505-0081
Sotalol HydrochlorideSotalol hydrochloride 240 mg/1TabletOralApotex Corp.60505-0082
Sotalol HydrochlorideSotalol hydrochloride 120 mg/1TabletOralApotex Corp.60505-0159
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralProficient Rx LP63187-804
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralAmerican Health Packaging68084-654
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralBryant Ranch Prepack71335-0260
Sotalol HydrochlorideSotalol hydrochloride 120 mg/1TabletOralBryant Ranch Prepack71335-1125
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-723
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-849
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralBryant Ranch Prepack72162-2118

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