Prescription drug · NDA
Quillivant XR (Methylphenidate hydrochloride) NDC 24478-321
Methylphenidate hydrochloride 300 mg/60mL · Suspension, Extended release · Oral · NextWave Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24478-321-02 | 24478032102 | 1 BOTTLE in 1 CARTON (24478-321-02) / 60 mL in 1 BOTTLEMarketed from Oct 1, 2012 |
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)
- Quillivant XRSuffix: XR
- Generic name (nonproprietary)
- methylphenidate hydrochloride
- Active ingredients
- Methylphenidate hydrochloride — 300 mg/60mL
- 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 202100
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 24478-321_b013d8b4-c598-45d9-9934-51fca4539a24SPL ID b013d8b4-c598-45d9-9934-51fca4539a24SPL set ID c2dc2109-44a6-4797-b04e-18761dd9d45aRxCUI 1312583, 1312589UNII 4B3SC438HI
- Pharmacologic class
- Central Nervous System Stimulant
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
N424478032102followed by a unit qualifier and the quantityPackage 24478-0321-02. 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)
QUILLIVANT XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 ) ]. Limitations of Use The use of QUILLIVANT XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions ( 5.7 ), Use in Specific Populations ( 8.4 )]. QUILLIVANT XR is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). ( 1 ) Limitations of Use The use of QUILLIVANT XR is not recommended in pediatric patient…
Excerpt only. Read the full label for complete information.
About NDC 24478-321
- What is NDC 24478-321?
- 24478-321 is the product NDC for Quillivant XR (methylphenidate hydrochloride), Methylphenidate hydrochloride 300 mg/60mL suspension, extended release, listed with the FDA by NextWave Pharmaceuticals, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Quillivant XR (Methylphenidate hydrochloride).
- What is the active ingredient?
- Methylphenidate 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 Quillivant XR?
- 3 other product NDCs are listed under this name. See all Quillivant XR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Quillivant XR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Quillivant XRmethylphenidate hydrochloride | Methylphenidate hydrochloride 900 mg/180mL | Suspension, Extended releaseOral | NextWave Pharmaceuticals, Inc | 24478-324 | 24478-0324-06 |
| Quillivant XRmethylphenidate hydrochloride | Methylphenidate hydrochloride 750 mg/150mL | Suspension, Extended releaseOral | NextWave Pharmaceuticals, Inc | 24478-323 | 24478-0323-05 |
| Quillivant XRmethylphenidate hydrochloride | Methylphenidate hydrochloride 600 mg/120mL | Suspension, Extended releaseOral | NextWave Pharmaceuticals, Inc | 24478-322 | 24478-0322-04 |
Other NDCs under NDA 202100
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Quillivant XRmethylphenidate hydrochloride | Methylphenidate hydrochloride 750 mg/150mL | Suspension, Extended releaseOral | NextWave Pharmaceuticals, Inc | 24478-323 |
| Quillivant XRmethylphenidate hydrochloride | Methylphenidate hydrochloride 600 mg/120mL | Suspension, Extended releaseOral | NextWave Pharmaceuticals, Inc | 24478-322 |
| Quillivant XRmethylphenidate hydrochloride | Methylphenidate hydrochloride 900 mg/180mL | Suspension, Extended releaseOral | NextWave Pharmaceuticals, Inc | 24478-324 |