Methylphenidate NDC 0378-8260

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-8260Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-8260Add 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
0378-8260-93	00378826093	30 POUCH in 1 CARTON (0378-8260-93) / 1 PATCH in 1 POUCH (0378-8260-16) / 9 h in 1 PATCHMarketed from Jun 27, 2022

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): Methylphenidate
Generic name (nonproprietary): methylphenidate
Active ingredients: Methylphenidate — 1.1 mg/h
Dosage form: Patch
Route: Transdermal
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206497
Marketing start: Jun 27, 2022
Marketing end: Apr 30, 2027
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 0378-8260_c5b3220c-d8cc-42a7-a0e8-3cc1ccc3d535SPL ID c5b3220c-d8cc-42a7-a0e8-3cc1ccc3d535SPL set ID 1643b6a5-80da-4d4f-8c5f-feb907875702RxCUI 753436, 753438, 753440, 753441UNII 207ZZ9QZ49
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

N400378826093 followed by a unit qualifier and the quantity

Package 00378-8260-93. 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 7, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Methylphenidate transdermal system is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. Limitations of Us e The use of methylphenidate transdermal system 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 (5.8) , Use in Specific Populations (8.4) ] . Methylphenidate transdermal system is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric pa…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206497

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

FDA NDC Directory listings under ANDA 206497
Product	Strength	Form · route	Labeler	Product NDC
Methylphenidate	Methylphenidate 1.6 mg/h	PatchTransdermal	Mylan Pharmaceuticals Inc.	0378-8261
Methylphenidate	Methylphenidate 2.2 mg/h	PatchTransdermal	Mylan Pharmaceuticals Inc.	0378-8262
Methylphenidate	Methylphenidate 3.3 mg/h	PatchTransdermal	Mylan Pharmaceuticals Inc.	0378-8263