Memantine and Donepezil NDC 33342-312

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-312Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0312Add 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
33342-312-07	33342031207	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-312-07)Marketed from Jul 15, 2025
33342-312-10	33342031210	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-312-10)Marketed from Jul 15, 2025
33342-312-12	33342031212	10 BLISTER PACK in 1 CARTON (33342-312-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jul 15, 2025

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): Memantine and Donepezil
Generic name (nonproprietary): memantine and donepezil
Active ingredients: Memantine hydrochloride — 14 mg/1Donepezil hydrochloride — 10 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Macleods Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208672
Marketing start: Jul 15, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Cholinesterase Inhibitors (Mechanism)NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 33342-312_3d9a23dc-8cbe-47c3-a048-70d86cb9dc14SPL ID 3d9a23dc-8cbe-47c3-a048-70d86cb9dc14SPL set ID 3d9a23dc-8cbe-47c3-a048-70d86cb9dc14RxCUI 1599803, 1599805UNII JY0WD0UA60, 3O2T2PJ89DUPC 0333342312075, 0333342312105, 0333342313072, 0333342313102
Pharmacologic class: Cholinesterase Inhibitor; N-methyl-D-aspartate Receptor Antagonist

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

N433342031207 followed by a unit qualifier and the quantity

Package 33342-0312-07. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 208672

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

FDA NDC Directory listings under ANDA 208672
Product	Strength	Form · route	Labeler	Product NDC
Memantine and Donepezil	Memantine hydrochloride 28 mg/1; Donepezil hydrochloride 10 mg/1	Capsule, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-313