Prescription drug · NDA
Onyda XR (Clonidine hydrochloride) NDC 24478-148
Clonidine hydrochloride .1 mg/mL · Suspension, Extended release · Oral · NextWave Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24478-148-01 | 2447801480124478014801 | 7 mL in 1 BOTTLE (24478-148-01)Marketed from Aug 13, 2024 · Sample package | |
| 24478-148-03 | 2447801480324478014803 | 30 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
N424478014801followed by a unit qualifier and the quantityPackage 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.
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.