Methylphenidate Hydrochloride NDC 16729-479

NDC codes

FDA NDC Directory

Product NDC (as listed)16729-479Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16729-0479Add 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
16729-479-01	16729047901	100 TABLET in 1 BOTTLE (16729-479-01)Marketed from Dec 17, 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 Hydrochloride
Generic name (nonproprietary): methylphenidate hydrochloride
Active ingredients: Methylphenidate hydrochloride — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Accord Healthcare, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213936
Marketing start: Dec 17, 2020
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 16729-479_1b2d1579-1bb4-cc17-e063-6294a90a4fa7SPL ID 1b2d1579-1bb4-cc17-e063-6294a90a4fa7SPL set ID 4f3c91e6-4576-4326-bdab-7d8fb7c09bb8RxCUI 1091150, 1091392, 1091497UNII 4B3SC438HIUPC 0316729479011, 0316729480017, 0316729478014
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

N416729047901 followed by a unit qualifier and the quantity

Package 16729-0479-01. 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 Jun 18, 2024. 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 is 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)

Other NDCs under ANDA 213936

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

FDA NDC Directory listings under ANDA 213936
Product	Strength	Form · route	Labeler	Product NDC
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 5 mg/1	TabletOral	Accord Healthcare, Inc.	16729-478
Methylphenidate Hydrochloride	Methylphenidate hydrochloride 20 mg/1	TabletOral	Accord Healthcare, Inc.	16729-480