Donepezil Hydrochloride NDC 33342-029

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-029Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0029Add 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
33342-029-06	33342002906	3 BLISTER PACK in 1 CARTON (33342-029-06) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Dec 14, 2012
33342-029-07	33342002907	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (33342-029-07)Marketed from Dec 14, 2012
33342-029-12	33342002912	10 BLISTER PACK in 1 CARTON (33342-029-12) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Dec 14, 2012
33342-029-60	33342002960	4 BLISTER PACK in 1 CARTON (33342-029-60) / 7 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Dec 14, 2012

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, Orally disintegrating
Route: Oral
Labeler: Macleods Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201787
Marketing start: Dec 14, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Cholinesterase Inhibitors (Mechanism)
Identifiers: Product ID 33342-029_4bf742a3-3c8f-4bd3-b973-54370cbef345SPL ID 4bf742a3-3c8f-4bd3-b973-54370cbef345SPL set ID 06dd25a5-1bf2-446d-ad75-ff9d55117660RxCUI 997220, 997223, 997226, 997229, 1100184UNII 3O2T2PJ89DUPC 0333342061102, 0333342061072, 0333342030078, 0333342027108, 0333342027078, 0333342029072, 0333342029607, 0333342027153, 0333342028150, 0333342030603
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

N433342002906 followed by a unit qualifier and the quantity

Package 33342-0029-06. 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 Aug 11, 2023.

Indications (excerpt from the label)

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)