What is NDC 65038-561?

65038-561 is the product NDC for Azstarys, Serdexmethylphenidate chloride 52.3 mg/1; Dexmethylphenidate hydrochloride 10.4 mg/1 capsule, listed with the FDA by Commave Sub, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Azstarys (Serdexmethylphenidate and Dexmethylphenidate).

What is the active ingredient?

Serdexmethylphenidate chloride, Dexmethylphenidate hydrochloride.

Commave Sub, LLC, NDC labeler code 65038. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Azstarys?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Azstarys NDC 65038-561 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65038-561Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65038-0561Add 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 NDC	11-digit (billing)	Package	Copy
65038-561-99	65038056199	100 CAPSULE in 1 BOTTLE, PLASTIC (65038-561-99)Marketed from Jul 16, 2021

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): Azstarys
Generic name (nonproprietary): serdexmethylphenidate and dexmethylphenidate
Active ingredients: Serdexmethylphenidate chloride — 52.3 mg/1Dexmethylphenidate hydrochloride — 10.4 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Commave Sub, LLCNDC labeler code 65038
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 212994
Marketing start: Jul 16, 2021
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 65038-561_515506d2-5c3d-92d2-e063-6394a90a0603SPL ID 515506d2-5c3d-92d2-e063-6394a90a0603SPL set ID 00b5e716-5564-4bbd-acaf-df2bc45a5663RxCUI 2562186, 2562187, 2562191, 2562194, 2562199, 2562204UNII 1678OK0E08, FN54BT298YUPC 0365038561993, 0365038429996, 0365038286995
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

N465038056199 followed by a unit qualifier and the quantity

Package 65038-0561-99. 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 May 11, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

AZSTARYS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older. Limitations of Use The use of AZSTARYS 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 )]. AZSTARYS is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older. ( 1 ) Limitations of Use The use of AZSTARYS is not recommend…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65038-561

What is NDC 65038-561?: 65038-561 is the product NDC for Azstarys, Serdexmethylphenidate chloride 52.3 mg/1; Dexmethylphenidate hydrochloride 10.4 mg/1 capsule, listed with the FDA by Commave Sub, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Azstarys (Serdexmethylphenidate and Dexmethylphenidate).
What is the active ingredient?: Serdexmethylphenidate chloride, Dexmethylphenidate hydrochloride.
Who is the labeler?: Commave Sub, LLC, NDC labeler code 65038. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Azstarys?: 2 other product NDCs are listed under this name. See all Azstarys NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Azstarys NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Azstarysserdexmethylphenidate and dexmethylphenidate	Serdexmethylphenidate chloride 26.1 mg/1; Dexmethylphenidate hydrochloride 5.2 mg/1	CapsuleOral	Commave Sub, LLC	65038-286	65038-0286-99
Azstarysserdexmethylphenidate and dexmethylphenidate	Serdexmethylphenidate chloride 39.2 mg/1; Dexmethylphenidate hydrochloride 7.8 mg/1	CapsuleOral	Commave Sub, LLC	65038-429	65038-0429-99

Other NDCs under NDA 212994

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

FDA NDC Directory listings under NDA 212994
Product	Strength	Form · route	Labeler	Product NDC
Azstarysserdexmethylphenidate and dexmethylphenidate	Serdexmethylphenidate chloride 26.1 mg/1; Dexmethylphenidate hydrochloride 5.2 mg/1	CapsuleOral	Commave Sub, LLC	65038-286
Azstarysserdexmethylphenidate and dexmethylphenidate	Serdexmethylphenidate chloride 39.2 mg/1; Dexmethylphenidate hydrochloride 7.8 mg/1	CapsuleOral	Commave Sub, LLC	65038-429