Concerta (methylphenidate hydrochloride) NDC 50458-585

NDC codes

FDA NDC Directory

Product NDC (as listed)50458-585Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50458-0585Add 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
50458-585-01	50458058501	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-585-01)Marketed from Aug 1, 2000

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): Concerta
Generic name (nonproprietary): methylphenidate hydrochloride
Active ingredients: Methylphenidate hydrochloride — 18 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Janssen Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021121
Marketing start: Aug 1, 2000
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 50458-585_64d7c1e1-e7ed-4d74-a44d-13b4da64af9aSPL ID 64d7c1e1-e7ed-4d74-a44d-13b4da64af9aSPL set ID 1a88218c-5b18-4220-8f56-526de1a276cdRxCUI 1091155, 1091157, 1091170, 1091172, 1091185, 1091187, 1091210, 1091212UNII 4B3SC438HIUPC 0350458585018, 0350458587012, 0350458588019, 0350458586015
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

N450458058501 followed by a unit qualifier and the quantity

Package 50458-0585-01. 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 Apr 20, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

CONCERTA is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use The use of CONCERTA 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) and Use in Specific Populations (8.4) ]. CONCERTA is a CNS stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old. ( 1 ) Limitations of Use The use of CONCERTA is not recommended in pediatric patients youn…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021121

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

FDA NDC Directory listings under NDA 021121
Product	Strength	Form · route	Labeler	Product NDC
Concertamethylphenidate hydrochloride	Methylphenidate hydrochloride 36 mg/1	Tablet, Extended releaseOral	Janssen Pharmaceuticals, Inc.	50458-586
Concertamethylphenidate hydrochloride	Methylphenidate hydrochloride 54 mg/1	Tablet, Extended releaseOral	Janssen Pharmaceuticals, Inc.	50458-587
Concertamethylphenidate hydrochloride	Methylphenidate hydrochloride 27 mg/1	Tablet, Extended releaseOral	Janssen Pharmaceuticals, Inc.	50458-588