Donepezil Hydrochloride NDC 71209-019

NDC codes

FDA NDC Directory

Product NDC (as listed)71209-019Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71209-0019Add 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
71209-019-01	71209001901	30 TABLET, FILM COATED in 1 BOTTLE (71209-019-01)Marketed from Nov 24, 2018
71209-019-04	71209001904	90 TABLET, FILM COATED in 1 BOTTLE (71209-019-04)Marketed from Nov 24, 2018
71209-019-11	71209001911	1000 TABLET, FILM COATED in 1 BOTTLE (71209-019-11)Marketed from Nov 24, 2018

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: Cadila Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204609
Marketing start: Jan 30, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Cholinesterase Inhibitors (Mechanism)
Identifiers: Product ID 71209-019_e33aac76-604d-43cb-8be4-d58ce3b2b6f8SPL ID e33aac76-604d-43cb-8be4-d58ce3b2b6f8SPL set ID 37aa1285-774a-4714-a4af-4e3fa9fa7f55RxCUI 997223, 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

N471209001901 followed by a unit qualifier and the quantity

Package 71209-0019-01. 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 Dec 27, 2022.

Indications (excerpt from the label)

Donepezil Hydrochloride Tablets 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 204609

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

FDA NDC Directory listings under ANDA 204609
Product	Strength	Form · route	Labeler	Product NDC
Donepezil Hydrochloride	Donepezil hydrochloride 10 mg/1	Tablet, Film coatedOral	Cadila Pharmaceuticals Limited	71209-020