What is NDC 33342-029?

33342-029 is the product NDC for Donepezil Hydrochloride, Donepezil hydrochloride 5 mg/1 tablet, orally disintegrating, listed with the FDA by Macleods Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Donepezil Hydrochloride?

60 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

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	3334200290633342002906	3 BLISTER PACK in 1 CARTON (33342-029-06) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Dec 14, 2012
33342-029-07	3334200290733342002907	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (33342-029-07)Marketed from Dec 14, 2012
33342-029-12	3334200291233342002912	10 BLISTER PACK in 1 CARTON (33342-029-12) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Dec 14, 2012
33342-029-60	3334200296033342002960	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 LimitedNDC labeler code 33342
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)

About NDC 33342-029

What is NDC 33342-029?: 33342-029 is the product NDC for Donepezil Hydrochloride, Donepezil hydrochloride 5 mg/1 tablet, orally disintegrating, listed with the FDA by Macleods Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Donepezil Hydrochloride.
What is the active ingredient?: Donepezil hydrochloride.
Who is the labeler?: Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Donepezil Hydrochloride?: 60 other product NDCs are listed under this name. See all Donepezil Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Donepezil Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Donepezil hydrochloride	Donepezil hydrochloride 23 mg/1	Tablet, Film coatedOral	Dr. Reddys Laboratories Limited	55111-302	55111-0302-3055111-0302-90
Donepezil Hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4392	70518-4392-00
Donepezil Hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1476	67046-1476-03
Donepezil Hydrochloride	Donepezil hydrochloride 5 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8711	68788-8711-0368788-8711-0668788-8711-09
Donepezil Hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8208	68788-8208-0368788-8208-0668788-8208-09
Donepezil Hydrochloride	Donepezil hydrochloride 10 mg/1	Tablet, Film coatedOral	DirectRx	72189-265	72189-0265-90
Donepezil Hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-031	72189-0031-30
donepezil hydrochloride	Donepezil hydrochloride 10 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1666	70518-1666-0070518-1666-01
Donepezil Hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	Cadila Pharmaceuticals Limited	71209-019	71209-0019-0171209-0019-0471209-0019-11
Donepezil Hydrochloride	Donepezil hydrochloride 10 mg/1	Tablet, Film coatedOral	Cadila Pharmaceuticals Limited	71209-020	71209-0020-0171209-0020-0471209-0020-11

All 61 Donepezil Hydrochloride NDCs

Other NDCs under ANDA 201787

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

FDA NDC Directory listings under ANDA 201787
Product	Strength	Form · route	Labeler	Product NDC
Donepezil Hydrochloride	Donepezil hydrochloride 10 mg/1	Tablet, Orally disintegratingOral	Macleods Pharmaceuticals Limited	33342-030