Donepezil Hydrochloride NDC 70518-4392

NDC codes

FDA NDC Directory

Product NDC (as listed)70518-4392Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70518-4392Add 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
70518-4392-0	70518439200	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4392-0)Marketed from Jul 15, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Donepezil Hydrochloride
Generic name (nonproprietary): donepezil hydrochloride
Active ingredients: Donepezil hydrochloride — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: REMEDYREPACK INC.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090056
Marketing start: Jul 15, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Cholinesterase Inhibitors (Mechanism)
Identifiers: Product ID 70518-4392_5b122589-0649-10ae-e063-6394a90aaa60SPL ID 5b122589-0649-10ae-e063-6394a90aaa60SPL set ID de96349a-5fee-4de9-921c-e453d44b3203RxCUI 997229UNII 3O2T2PJ89D
Pharmacologic class: Cholinesterase Inhibitor

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

N470518439200 followed by a unit qualifier and the quantity

Package 70518-4392-00. 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 Sep 9, 2026.

Indications (excerpt from the label)

Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease. Donepezil is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s Disease (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)