Donepezil Hydrochloride NDC 46708-295

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-295Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0295Add 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
46708-295-10	46708029510	100 TABLET, FILM COATED in 1 CARTON (46708-295-10)Marketed from Jan 29, 2016
46708-295-30	46708029530	30 TABLET, FILM COATED in 1 BOTTLE (46708-295-30)Marketed from Jan 29, 2016
46708-295-90	46708029590	90 TABLET, FILM COATED in 1 BOTTLE (46708-295-90)Marketed from Jan 29, 2016
46708-295-91	46708029591	1000 TABLET, FILM COATED in 1 BOTTLE (46708-295-91)Marketed from Jan 29, 2016

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 — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Alembic Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201724
Marketing start: Jan 29, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Cholinesterase Inhibitors (Mechanism)
Identifiers: Product ID 46708-295_f0627628-81b1-4b14-b49d-1e68b350146fSPL ID f0627628-81b1-4b14-b49d-1e68b350146fSPL set ID bc570682-413b-46fb-a069-c2986884bfceRxCUI 997223, 997229UNII 3O2T2PJ89DUPC 0346708295301, 0346708296308
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

N446708029510 followed by a unit qualifier and the quantity

Package 46708-0295-10. 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 Jan 27, 2023.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE Donepezil hydrochloride is 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)

Other NDCs under ANDA 201724

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

FDA NDC Directory listings under ANDA 201724
Product	Strength	Form · route	Labeler	Product NDC
Donepezil Hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-092
Donepezil Hydrochloride	Donepezil hydrochloride 10 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-093
Donepezil Hydrochloride	Donepezil hydrochloride 10 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-296