Prescription drug · NDA
Xelstrym (Dextroamphetamine) NDC 68968-0220
Dextroamphetamine 18 mg/1 · Patch, Extended release · Transdermal · Noven Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68968-0220-3 | 6896802200368968022003 | 30 POUCH in 1 CARTON (68968-0220-3) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (68968-0220-1)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 — 18 mg/1
- Dosage form
- Patch, Extended release
- Route
- Transdermal
- Labeler
- Noven Therapeutics, LLCNDC labeler code 68968
- 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 68968-0220_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
N468968022003followed by a unit qualifier and the quantityPackage 68968-0220-03. 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.
About NDC 68968-0220
- What is NDC 68968-0220?
- 68968-0220 is the product NDC for Xelstrym (dextroamphetamine), Dextroamphetamine 18 mg/1 patch, extended release, listed with the FDA by Noven Therapeutics, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xelstrym (Dextroamphetamine).
- What is the active ingredient?
- Dextroamphetamine.
- Who is the labeler?
- Noven Therapeutics, LLC, NDC labeler code 68968. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xelstrym?
- 3 other product NDCs are listed under this name. See all Xelstrym NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Xelstrym products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Xelstrymdextroamphetamine | Dextroamphetamine 4.5 mg/1 | Patch, Extended releaseTransdermal | Noven Therapeutics, LLC | 68968-0205 | 68968-0205-03 |
| Xelstrymdextroamphetamine | Dextroamphetamine 9 mg/1 | Patch, Extended releaseTransdermal | Noven Therapeutics, LLC | 68968-0210 | 68968-0210-03 |
| Xelstrymdextroamphetamine | Dextroamphetamine 13.5 mg/1 | Patch, Extended releaseTransdermal | Noven Therapeutics, LLC | 68968-0215 | 68968-0215-03 |
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 4.5 mg/1 | Patch, Extended releaseTransdermal | Noven Therapeutics, LLC | 68968-0205 |
| 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 |