Methylphenidate Hydrochloride NDC 57664-229

NDC codes

FDA NDC Directory

Product NDC (as listed)57664-229Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57664-0229Add 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
57664-229-08	57664022908	100 TABLET in 1 BOTTLE (57664-229-08)Marketed from Aug 16, 2013
57664-229-13	57664022913	500 TABLET in 1 BOTTLE (57664-229-13)Marketed from Aug 16, 2013
57664-229-18	57664022918	1000 TABLET in 1 BOTTLE (57664-229-18)Marketed from Aug 16, 2013
57664-229-83	57664022983	30 TABLET in 1 BOTTLE (57664-229-83)Marketed from Aug 16, 2013
57664-229-88	57664022988	100 TABLET in 1 BOTTLE (57664-229-88)Marketed from Aug 16, 2013

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 Hydrochloride
Generic name (nonproprietary): methylphenidate hydrochloride
Active ingredients: Methylphenidate hydrochloride — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090710
Marketing start: Aug 16, 2013
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 57664-229_2f1c1df8-491a-08c9-e063-6394a90a1d06SPL ID 2f1c1df8-491a-08c9-e063-6394a90a1d06SPL set ID 1a89b390-0cd5-45cb-9e70-20de44652c56RxCUI 1091150, 1091392, 1091497UNII 4B3SC438HIUPC 0357664228883, 0357664229880, 0357664230886
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

N457664022908 followed by a unit qualifier and the quantity

Package 57664-0229-08. 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 Feb 27, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Methylphenidate hydrochloride tablets are indicated for the treatment of: Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults Narcolepsy Methylphenidate hydrochloride tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy (1).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)