Dexmethylphenidate hydrochloride NDC 0115-1709

NDC codes

FDA NDC Directory

Product NDC (as listed)0115-1709Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00115-1709Add 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
0115-1709-01	00115170901	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-1709-01)Marketed from Jul 5, 2017

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Dexmethylphenidate hydrochloride
Generic name (nonproprietary): dexmethylphenidate hydrochloride
Active ingredients: Dexmethylphenidate hydrochloride — 25 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203614
Marketing start: Jul 5, 2017
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 0115-1709_b9254c68-2d68-4a6d-874b-d85a32ce4893SPL ID b9254c68-2d68-4a6d-874b-d85a32ce4893SPL set ID be7019d7-eb3e-48eb-b6ba-0ffefae6dcd0RxCUI 1101926, 1101932UNII 1678OK0E08UPC 0301151710016, 0301151709010
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

N400115170901 followed by a unit qualifier and the quantity

Package 00115-1709-01. 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 Oct 9, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14) ] . Limitations of Use The use of dexmethylphenidate hydrochloride extended-release capsules 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) ]. Dexmethylphenidate hydrochloride extended-release capsules are a central nervous system (CNS) stimulant indicated for the treatment of Atte…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203614

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

FDA NDC Directory listings under ANDA 203614
Product	Strength	Form · route	Labeler	Product NDC
Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride 35 mg/1	Capsule, Extended releaseOral	Amneal Pharmaceuticals of New York LLC	0115-1710