What is NDC 33342-313?

33342-313 is the product NDC for Memantine and Donepezil, Memantine hydrochloride 28 mg/1; Donepezil hydrochloride 10 mg/1 capsule, extended release, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Memantine hydrochloride, Donepezil hydrochloride.

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 Memantine and Donepezil?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Memantine and Donepezil NDC 33342-313

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-313Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0313Add 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
33342-313-07	3334203130733342031307	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-313-07)Marketed from Jul 15, 2025
33342-313-10	3334203131033342031310	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-313-10)Marketed from Jul 15, 2025
33342-313-56	3334203135633342031356	10 BLISTER PACK in 1 CARTON (33342-313-56) / 14 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 — 28 mg/1Donepezil hydrochloride — 10 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Macleods Pharmaceuticals LimitedNDC labeler code 33342
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 33342-313_3d9a23dc-8cbe-47c3-a048-70d86cb9dc14SPL ID 3d9a23dc-8cbe-47c3-a048-70d86cb9dc14SPL set ID 3d9a23dc-8cbe-47c3-a048-70d86cb9dc14RxCUI 1599803, 1599805UNII 3O2T2PJ89D, JY0WD0UA60UPC 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

N433342031307 followed by a unit qualifier and the quantity

Package 33342-0313-07. 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

Current FDA label (SPL), effective Jul 10, 2025.

Indications (excerpt from the label)

Memantine and donepezil hydrochlorides extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily. Memantine and donepezil hydrochlorides extended-release capsules are a combination of memantine hydrochloride, an NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor, indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-313

What is NDC 33342-313?: 33342-313 is the product NDC for Memantine and Donepezil, Memantine hydrochloride 28 mg/1; Donepezil hydrochloride 10 mg/1 capsule, extended release, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Memantine and Donepezil.
What is the active ingredient?: Memantine hydrochloride, 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 Memantine and Donepezil?: 1 other product NDC are listed under this name. See all Memantine and Donepezil 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 Memantine and Donepezil NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Memantine and Donepezil	Memantine hydrochloride 14 mg/1; Donepezil hydrochloride 10 mg/1	Capsule, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-312	33342-0312-0733342-0312-1033342-0312-12

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 14 mg/1; Donepezil hydrochloride 10 mg/1	Capsule, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-312