NDC codes

FDA NDC Directory
Product NDC (as listed)60505-0222Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60505-0222Add 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
60505-0222-160505022201100 TABLET in 1 BOTTLE, PLASTIC (60505-0222-1)Marketed from Sep 9, 2003
60505-0222-2605050222021000 TABLET in 1 BOTTLE, PLASTIC (60505-0222-2)Marketed from Sep 9, 2003

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
Apotex Corp.NDC labeler code 60505
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076214
Marketing start
Listing expires
Other FDA classes
Adrenergic beta-Antagonists (Mechanism)Cardiac Rhythm Alteration (Physiologic effect)
Identifiers
Product ID 60505-0222_56c7802b-7509-33d1-228e-44b9d9a6e2e4SPL ID 56c7802b-7509-33d1-228e-44b9d9a6e2e4
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

N460505022201 followed by a unit qualifier and the quantity

Package 60505-0222-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 60505-0222

What is NDC 60505-0222?
60505-0222 is the product NDC for Sotalol Hydrochloride, Sotalol hydrochloride 80 mg/1 tablet, listed with the FDA by Apotex Corp.. It has 2 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?
Apotex Corp., NDC labeler code 60505. 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 076214

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

FDA NDC Directory listings under ANDA 076214
ProductStrengthForm · routeLabelerProduct NDC
Sotalol HydrochlorideSotalol hydrochloride 120 mg/1TabletOralApotex Corp.60505-0223
Sotalol HydrochlorideSotalol hydrochloride 160 mg/1TabletOralApotex Corp.60505-0224
Sotalol HydrochlorideSotalol hydrochloride 80 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-074

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