NDC 0406-1850

NDC codes

FDA NDC Directory

Product NDC (as listed)0406-1850Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00406-1850Add 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
0406-1850-01	00406185001	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0406-1850-01)Marketed from Sep 29, 2015

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 — 50 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: SpecGx LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203583
Marketing start: Sep 29, 2015
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 0406-1850_8ba92af8-0db9-4347-95c3-bd06680fc85fSPL ID 8ba92af8-0db9-4347-95c3-bd06680fc85fSPL set ID 9e11e093-4ff3-4bed-8fe9-3ee460b47303RxCUI 1806181, 1806187, 1806189, 1806191, 1806193, 1806197UNII 4B3SC438HIUPC 0304061840019, 0304061810012, 0304061830010, 0304061860017, 0304061820011, 0304061850018
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

N400406185001 followed by a unit qualifier and the quantity

Package 00406-1850-01. 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 Dec 1, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Methylphenidate HCl extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use The use of methylphenidate HCl 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)] . Methylphenidate HCl extended-release capsules are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203583

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

FDA NDC Directory listings under ANDA 203583
Product	Strength	Form · route	Labeler	Product NDC
Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochloride	Methylphenidate hydrochloride 10 mg/1	Capsule, Extended releaseOral	SpecGx LLC	0406-1810
Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochloride	Methylphenidate hydrochloride 20 mg/1	Capsule, Extended releaseOral	SpecGx LLC	0406-1820
Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochloride	Methylphenidate hydrochloride 30 mg/1	Capsule, Extended releaseOral	SpecGx LLC	0406-1830
Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochloride	Methylphenidate hydrochloride 40 mg/1	Capsule, Extended releaseOral	SpecGx LLC	0406-1840
Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochloride	Methylphenidate hydrochloride 60 mg/1	Capsule, Extended releaseOral	SpecGx LLC	0406-1860

Methylphenidate Hydrochloride Extended-Release NDC 0406-1850