Prescription drug · NDA
Xelstrym (dextroamphetamine) NDC 68968-0205
Dextroamphetamine 4.5 mg/1 · Patch, Extended release · Transdermal · Noven Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68968-0205-3 | 68968020503 | 30 POUCH in 1 CARTON (68968-0205-3) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (68968-0205-1)Marketed from May 15, 2023 |
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)
- Xelstrym
- Generic name (nonproprietary)
- dextroamphetamine
- Active ingredients
- Dextroamphetamine — 4.5 mg/1
- Dosage form
- Patch, Extended release
- Route
- Transdermal
- Labeler
- Noven Therapeutics, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215401
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 68968-0205_11163145-d173-4320-aac9-92069f0cbf4aSPL ID 11163145-d173-4320-aac9-92069f0cbf4aSPL set ID 0862f02a-72a8-41cc-8845-57cf4974bb6fRxCUI 2624701, 2624708, 2624712, 2624715, 2624726, 2624729, 2624732, 2624735UNII TZ47U051FI
- 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. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468968020503followed by a unit qualifier and the quantityPackage 68968-0205-03. 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)
XELSTRYM ® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see CLINICAL STUDIES (14) ] . Limitations of Use The use of XELSTRYM 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) ]. XELSTRYM is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older ( 1 …
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 215401
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 |
|---|---|---|---|---|
| Xelstrymdextroamphetamine | Dextroamphetamine 9 mg/1 | Patch, Extended releaseTransdermal | Noven Therapeutics, LLC | 68968-0210 |
| Xelstrymdextroamphetamine | Dextroamphetamine 13.5 mg/1 | Patch, Extended releaseTransdermal | Noven Therapeutics, LLC | 68968-0215 |
| Xelstrymdextroamphetamine | Dextroamphetamine 18 mg/1 | Patch, Extended releaseTransdermal | Noven Therapeutics, LLC | 68968-0220 |