Methylphenidate Hydrochloride NDC 16729-478

NDC codes

FDA NDC Directory

Product NDC (as listed)16729-478Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16729-0478Add 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
16729-478-01	16729047801	100 TABLET in 1 BOTTLE (16729-478-01)Marketed from Dec 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 Hydrochloride
Generic name (nonproprietary): methylphenidate hydrochloride
Active ingredients: Methylphenidate hydrochloride — 5 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 23, 2020
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 16729-478_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

N416729047801 followed by a unit qualifier and the quantity

Package 16729-0478-01. 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

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