NDC codes

FDA NDC Directory
Product NDC (as listed)24478-148Labeler and product segments. Claims need a package NDC.
Product NDC at billing width24478-0148Add 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
24478-148-0124478014801244780148017 mL in 1 BOTTLE (24478-148-01)Marketed from Aug 13, 2024 · Sample package
24478-148-03244780148032447801480330 mL in 1 BOTTLE (24478-148-03)Marketed from Aug 13, 2024

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)
Onyda XR
Generic name (nonproprietary)
clonidine hydrochloride
Active ingredients
Clonidine hydrochloride — .1 mg/mL
Dosage form
Suspension, Extended release
Route
Oral
Labeler
NextWave Pharmaceuticals, IncNDC labeler code 24478
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 217645
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha2-Agonists (Mechanism)
Identifiers
Product ID 24478-148_00de799f-c9cb-42b7-8471-5bde35108200SPL ID 00de799f-c9cb-42b7-8471-5bde35108200SPL set ID 4a15c850-9da5-4bdc-a34d-7f740a6149b7RxCUI 2690727, 2690735UNII W76I6XXF06UPC 0324478148010, 0324478148034
Pharmacologic class
Central alpha-2 Adrenergic Agonist

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

N424478014801 followed by a unit qualifier and the quantity

Package 24478-0148-01. 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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

ONYDA XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older [see Clinical Studies ( 14 )]. ONYDA XR is a centrally acting alpha 2 -adrenergic agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy or as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 24478-148

What is NDC 24478-148?
24478-148 is the product NDC for Onyda XR (clonidine hydrochloride), Clonidine hydrochloride .1 mg/mL suspension, extended release, listed with the FDA by NextWave Pharmaceuticals, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Onyda XR (Clonidine hydrochloride).
What is the active ingredient?
Clonidine hydrochloride.
Who is the labeler?
NextWave Pharmaceuticals, Inc, NDC labeler code 24478. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Onyda XR?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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