Methylphenidate Hydrochloride Extended-Release NDC 0406-0127

NDC codes

FDA NDC Directory

Product NDC (as listed)0406-0127Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00406-0127Add 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
0406-0127-01	00406012701	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-0127-01)Marketed from Dec 28, 2012

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 Hydrochloride Extended-ReleaseSuffix: Extended-Release
Generic name (nonproprietary): methylphenidate hydrochloride
Active ingredients: Methylphenidate hydrochloride — 27 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: SpecGx LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202608
Marketing start: Dec 28, 2012
Marketing end: Jun 30, 2027
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 0406-0127_24d8e2c3-6e4d-44b8-aafe-7c713b11af5aSPL ID 24d8e2c3-6e4d-44b8-aafe-7c713b11af5aSPL set ID b1b0f2ff-d9df-42ab-b471-226ecf97e075RxCUI 2001565, 2001566, 2001568UNII 4B3SC438HIUPC 0304060154018, 0304060136014, 0304060127012
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

N400406012701 followed by a unit qualifier and the quantity

Package 00406-0127-01. 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 Sep 1, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see Clinical Studies ( 14 )] . Methylphenidate hydrochloride extended-release tablets USP are a CNS stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202608

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

FDA NDC Directory listings under ANDA 202608
Product	Strength	Form · route	Labeler	Product NDC
Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochloride	Methylphenidate hydrochloride 54 mg/1	Tablet, Extended releaseOral	SpecGx LLC	0406-0154
Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochloride	Methylphenidate hydrochloride 36 mg/1	Tablet, Extended releaseOral	SpecGx LLC	0406-0136