Donepezil Hydrochloride NDC 62756-194

NDC codes

FDA NDC Directory

Product NDC (as listed)62756-194Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62756-0194Add 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
62756-194-18	62756019418	1000 TABLET, FILM COATED in 1 BOTTLE (62756-194-18)Marketed from Jun 17, 2015
62756-194-81	62756019481	90 TABLET, FILM COATED in 1 BOTTLE (62756-194-81)Marketed from Jun 17, 2015
62756-194-83	62756019483	30 TABLET, FILM COATED in 1 BOTTLE (62756-194-83)Marketed from Jun 17, 2015

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): Donepezil Hydrochloride
Generic name (nonproprietary): donepezil hydrochloride
Active ingredients: Donepezil hydrochloride — 23 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204293
Marketing start: Jun 17, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Cholinesterase Inhibitors (Mechanism)
Identifiers: Product ID 62756-194_65890f83-ea1b-4342-b403-6ebe155bc357SPL ID 65890f83-ea1b-4342-b403-6ebe155bc357SPL set ID 79ad107b-bb20-4ed3-89f0-d7c862f3957cRxCUI 997223, 997229, 1100184UNII 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

N462756019418 followed by a unit qualifier and the quantity

Package 62756-0194-18. 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 Oct 31, 2018.

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 hydrochloride 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)