Prescription drug · NDA
Dyanavel XR (Amphetamine) NDC 24478-106
Amphetamine 5 mg/1 · Tablet, Extended release · Oral · NextWave Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24478-106-01 | 24478010601 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-106-01)Marketed from Aug 1, 2022 |
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)
- Dyanavel XR
- Generic name (nonproprietary)
- amphetamine
- Active ingredients
- Amphetamine — 5 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- NextWave Pharmaceuticals, IncNDC labeler code 24478
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210526
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 24478-106_32c90701-fe4a-4d5a-b3bb-e9ccf0416eceSPL ID 32c90701-fe4a-4d5a-b3bb-e9ccf0416eceSPL set ID ae304b29-0b40-40ec-ad0d-76b742d4a9b9RxCUI 1720586, 1720592, 2585460, 2585461, 2585462, 2585465, 2585468, 2585471, 2585473, 2585476UNII CK833KGX7EUPC 0324478102029, 0324478108014, 0324478110017, 0324478109011
- 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
N424478010601followed by a unit qualifier and the quantityPackage 24478-0106-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
DYANAVEL XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14) ]. Limitations of Use The use of DYANAVEL 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 (5.5) , Use in Specific Populations (8.4) ]. DYANAVEL XR is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older ( 1 ) Limitations of Use The use of DYAN…
Excerpt only. Read the full label for complete information.
About NDC 24478-106
- What is NDC 24478-106?
- 24478-106 is the product NDC for Dyanavel XR (amphetamine), Amphetamine 5 mg/1 tablet, 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?
- Dyanavel XR (Amphetamine).
- What is the active ingredient?
- Amphetamine.
- 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 Dyanavel XR?
- 4 other product NDCs are listed under this name. See all Dyanavel XR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dyanavel 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) |
|---|---|---|---|---|---|
| Dyanavel XRamphetamine | Amphetamine 10 mg/1 | Tablet, Extended releaseOral | NextWave Pharmaceuticals, Inc | 24478-108 | 24478-0108-01 |
| Dyanavel XRamphetamine | Amphetamine 15 mg/1 | Tablet, Extended releaseOral | NextWave Pharmaceuticals, Inc | 24478-109 | 24478-0109-01 |
| Dyanavel XRamphetamine | Amphetamine 20 mg/1 | Tablet, Extended releaseOral | NextWave Pharmaceuticals, Inc | 24478-110 | 24478-0110-01 |
| Dyanavel XRamphetamine | Amphetamine 2.5 mg/mL | Suspension, Extended releaseOral | NextWave Pharmaceuticals, Inc | 24478-102 | 24478-0102-0124478-0102-02 |
Other NDCs under NDA 210526
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 |
|---|---|---|---|---|
| Dyanavel XRamphetamine | Amphetamine 15 mg/1 | Tablet, Extended releaseOral | NextWave Pharmaceuticals, Inc | 24478-109 |
| Dyanavel XRamphetamine | Amphetamine 10 mg/1 | Tablet, Extended releaseOral | NextWave Pharmaceuticals, Inc | 24478-108 |
| Dyanavel XRamphetamine | Amphetamine 20 mg/1 | Tablet, Extended releaseOral | NextWave Pharmaceuticals, Inc | 24478-110 |