NDC codes

FDA NDC Directory
Product NDC (as listed)68968-0210Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68968-0210Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
68968-0210-36896802100330 POUCH in 1 CARTON (68968-0210-3) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (68968-0210-1)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 — 9 mg/1
Dosage form
Patch, Extended release
Route
Transdermal
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 68968-0210_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

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

N468968021003 followed by a unit qualifier and the quantity

Package 68968-0210-03. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 215401

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 215401
ProductStrengthForm · routeLabelerProduct NDC
XelstrymdextroamphetamineDextroamphetamine 4.5 mg/1Patch, Extended releaseTransdermalNoven Therapeutics, LLC68968-0205
XelstrymdextroamphetamineDextroamphetamine 13.5 mg/1Patch, Extended releaseTransdermalNoven Therapeutics, LLC68968-0215
XelstrymdextroamphetamineDextroamphetamine 18 mg/1Patch, Extended releaseTransdermalNoven Therapeutics, LLC68968-0220

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Xelstrym (dextroamphetamine) NDC 68968-0210 | Med-Code