Methylphenidate HCl NDC 39328-154

NDC codes

FDA NDC Directory

Product NDC (as listed)39328-154Labeler and product segments. Claims need a package NDC.

Product NDC at billing width39328-0154Add 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
39328-154-50	39328015450	500 mL in 1 BOTTLE (39328-154-50)Marketed from Apr 23, 2020

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): Methylphenidate HCl
Generic name (nonproprietary): methylphenidate hcl
Active ingredients: Methylphenidate hydrochloride — 10 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Patrin Pharma, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210764
Marketing start: Apr 23, 2020
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 39328-154_604deb17-dd9e-4386-a52b-248b1d5cb6b7SPL ID 604deb17-dd9e-4386-a52b-248b1d5cb6b7SPL set ID 7d66dbf9-3966-4949-b7c9-d2ca8c7f3278RxCUI 1091133, 1091341UNII 4B3SC438HI
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

N439328015450 followed by a unit qualifier and the quantity

Package 39328-0154-50. 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 22, 2020.

Indications (excerpt from the label)

INDICATIONS AND USAGE Attention Deficit Disorders, Narcolepsy Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate hcl oral solution is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, shor…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210764

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

FDA NDC Directory listings under ANDA 210764
Product	Strength	Form · route	Labeler	Product NDC
Methylphenidate HCl	Methylphenidate hydrochloride 5 mg/5mL	SolutionOral	Patrin Pharma, Inc.	39328-054